Trial Outcomes & Findings for GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 (NCT NCT05130255)
NCT ID: NCT05130255
Last Updated: 2026-06-18
Results Overview
Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Within 6 weeks after first IMP administration
Results posted on
2026-06-18
Participant Flow
Additional information: The trial contained three parts (Part A, Part B and Part C). Enrollment was completed for Part A of the study only. Part B and Part C were not opened for enrollment. Part A consisted of an Imaging portion and a Therapy portion. Participants with confirmed tumor uptake of 177 Lu in the Imaging portion, moved to the Therapy portion. After enrollment in Part A was completed, the study was terminated by choice of the Sponsor.
Participant milestones
| Measure |
Part A Cohort 1
0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 2
0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 3
1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 4
3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 5
1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 6
1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
5
|
5
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
1
|
2
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
4
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Baseline characteristics by cohort
| Measure |
Part A Cohort 1
n=2 Participants
0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 2
n=2 Participants
0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 3
n=5 Participants
1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 4
n=5 Participants
3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 5
n=3 Participants
1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA)
|
Part A Cohort 6
n=6 Participants
1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 12.73 • n=20 Participants
|
61 years
STANDARD_DEVIATION 11.31 • n=20 Participants
|
46.8 years
STANDARD_DEVIATION 21.72 • n=40 Participants
|
45.4 years
STANDARD_DEVIATION 24.30 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 6.81 • n=9 Participants
|
45.8 years
STANDARD_DEVIATION 23.72 • n=6 Participants
|
47.7 years
STANDARD_DEVIATION 19.72 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
20 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=20 Participants
|
2 participants
n=20 Participants
|
5 participants
n=40 Participants
|
5 participants
n=5 Participants
|
3 participants
n=9 Participants
|
6 participants
n=6 Participants
|
23 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Within 6 weeks after first IMP administrationPopulation: Patients evaluable for DLTs who either received the GD2-SADA dose and the 177Lu-DOTA dose in the imaging portion and in the therapy portion and who as a minimum was evaluated during the 6 weeks DLT evaluation period, or who had a DLT during the DLT evaluation period. No DLTs were observed in patients evaluable for DLTs. Only a minority of patients were evaluable for DLTs.
Adverse events meeting the criteria of a dose limiting toxicity are graded according to CTCAE version 5
Outcome measures
| Measure |
Cohort 1
0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Cohort 2
n=1 Participants
0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)
|
Cohort 3
n=2 Participants
1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Cohort 4
n=1 Participants
3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
|
Cohort 5
n=1 Participants
1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA)
|
Cohort 6
n=2 Participants
1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Cohort 4
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1
n=2 participants at risk
0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi): GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV
Therapy: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (200 mCi): GD2-SADA IV at 0.3 mg/kg followed by 200 mCi 177Lu-DOTA IV
|
Cohort 2
n=2 participants at risk
0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi): GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV
Therapy: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA
|
Cohort 3
n=5 participants at risk
1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA
|
Cohort 4
n=5 participants at risk
3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA
|
Cohort 5
n=3 participants at risk
1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi): GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)
|
Cohort 6
n=6 participants at risk
1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi): GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
Other adverse events
| Measure |
Cohort 1
n=2 participants at risk
0.3 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi): GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV
Therapy: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (200 mCi): GD2-SADA IV at 0.3 mg/kg followed by 200 mCi 177Lu-DOTA IV
|
Cohort 2
n=2 participants at risk
0.3 mg/kg GD2-SADA and 2-day Interval (2 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi): GD2-SADA IV at 0.3 mg/kg followed by 30 mCi 177Lu-DOTA IV
Therapy: GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 0.3 mg/kg followed by 200 mCi 177 Lu-DOTA
|
Cohort 3
n=5 participants at risk
1.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 1 mg/kg followed by 200 mCi 177 Lu-DOTA
|
Cohort 4
n=5 participants at risk
3.0 mg/kg GD2-SADA and 5-day Interval (5 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA IV at 3 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (3 mg/kg) 177Lu-DOTA (200 mCi): GD2-SADA 3 mg/kg followed by 200 mCi 177 Lu-DOTA
|
Cohort 5
n=3 participants at risk
1.0 mg/kg GD2-SADA and 4-day Interval (4 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi): GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)
|
Cohort 6
n=6 participants at risk
1.0 mg/kg GD2-SADA and 3-day Interval (3 days between GD2-SADA and 177Lu-DOTA)
Imaging: GD2-SADA (1 mg/kg) 177Lu-DOTA (30 mCi): GD2-SADA 1 mg/kg followed by 30 mCi 177 Lu-DOTA
Therapy: GD2-SADA (1 mg/kg) 177Lu-DOTA (100 mCi): GD2-SADA (1 mg/kg) followed by 177Lu-DOTA (100 mCi)
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
60.0%
3/5 • Number of events 6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
2/6 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
40.0%
2/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
66.7%
2/3 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
2/6 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
General disorders and administration site conditions
Chest discomfort
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
66.7%
2/3 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
66.7%
2/3 • Number of events 3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
General disorders and administration site conditions
Thirst
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
40.0%
2/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
2/6 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
40.0%
2/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
40.0%
2/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
40.0%
2/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Product issues
Device malfunction
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
16.7%
1/6 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
50.0%
1/2 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/3 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
66.7%
2/3 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/5 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
20.0%
1/5 • Number of events 2 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
33.3%
1/3 • Number of events 1 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
0.00%
0/6 • All-cause Mortality and Serious adverse events were assessed from signing the informed consent form until 4 weeks after the last IMP administration, up to 9 weeks. Non-serious adverse events were assessed from the day of first IMP administration until 4 weeks after the last IMP administration, up to 6 weeks.
The treatment in any cohort consisted of both an Imaging part and Therapy part. Only trial participants who showed tumor uptake of 177-Lu they would move to the Therapy part. Therefore, it is not considered relevant to split the Imaging dose and the Therapy dose of the drug complex.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place