Trial Outcomes & Findings for Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1. (NCT NCT03525392)

Last Updated: 2023-12-12

Results Overview

DLTs were defined for a list of predefined study medication-related adverse events (AEs) as specified in the protocol, according to the National Cancer Institute - Common Terminology Criteria for Adverse Events scale version 5.0 that occurred during the defined DLT assessment period (during Cycle 1 or 2).

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

From the start of the first study medication (Cycle 1 Day 1) up to EOCT, maximum of 16 weeks.

Results posted on

2023-12-12

Participant Flow

This Phase 1/2 first in human study was conducted in participants with unresectable, locally advanced or metastatic solid tumors expressing neurotensin receptor 1 (NTSR1) at 9 investigational sites in Belgium, France, the Netherlands, Switzerland and USA between 03 May 2018 and 28 April 2021. The sponsor terminated the study early during Cohort 5 in phase 1 dose escalation; phase 1 dose expansion and phase 2 were not started.

For phase 1, the core trial was up to 19 weeks (including screening) and comprised of 2 treatment cycles. If a participant had clinical benefit (Investigator judgment), they could receive up to 4 additional cycles after end of core trial (EOCT) provided certain other criteria were met. Long-term follow-up period was up to 5 years. Due to early termination, only results of the core trial are presented. 14 participants received a therapeutic dose of 177Lu-3BP-227 in phase 1 of the study.

Participant milestones

Participant milestones
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq Participants received 177Lu-3BP-227 2.5 Gigabecquerel (GBq) fractionated into 2 intravenous (IV) administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Overall Study STARTED	2	3	5	3	1
Overall Study COMPLETED	1	2	2	0	0
Overall Study NOT COMPLETED	1	1	3	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq Participants received 177Lu-3BP-227 2.5 Gigabecquerel (GBq) fractionated into 2 intravenous (IV) administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Overall Study Adverse Event	1	0	2	0	0
Overall Study Progressive disease	0	1	1	3	1

Baseline Characteristics

Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=2 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=3 Participants Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=5 Participants Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=3 Participants Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 Participants Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Total n=14 Participants Total of all reporting groups
Age, Continuous	70.0 years STANDARD_DEVIATION 4.2 • n=99 Participants	64.3 years STANDARD_DEVIATION 16.2 • n=107 Participants	64.0 years STANDARD_DEVIATION 7.2 • n=206 Participants	66.3 years STANDARD_DEVIATION 9.1 • n=7 Participants	77.0 years STANDARD_DEVIATION NA • n=31 Participants	66.4 years STANDARD_DEVIATION 9.2 • n=30 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	0 Participants n=31 Participants	4 Participants n=30 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants	10 Participants n=30 Participants
Race/Ethnicity, Customized Race Not Collected	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	10 Participants n=30 Participants
Race/Ethnicity, Customized White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants	1 Participants n=31 Participants	4 Participants n=30 Participants
Race/Ethnicity, Customized Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Black / African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Native Hawaiian / Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized American Indian / Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants	3 Participants n=7 Participants	1 Participants n=31 Participants	14 Participants n=30 Participants

PRIMARY outcome

Timeframe: From the start of the first study medication (Cycle 1 Day 1) up to EOCT, maximum of 16 weeks.

Population: Safety population contained all participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=2 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=3 Participants Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=5 Participants Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=3 Participants Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 Participants Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Measurements were performed at 0 to 1 hours, 2 to 4 hours, 16 to 24 hours, 40 to 48 hours, 72 to 96 hours post infusion in each treatment cycle.

Population: Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Since the study drug administered to different groups had same composition/specific activity, no difference in drug distribution was expected between groups. Because uptake results were expressed as percentage of administered 177Lu-3BP-227 activity, no difference in uptake was expected between groups and results were reported combining all groups.

177Lu-3BP-227 uptake in organs and lesions was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Uptake activity for organs of interest (i.e., body, bone marrow, left kidney, right kidney, healthy liver, and spleen) was determined. The uptake activity was expressed relatively to the injected 177Lu-3BP-227 activity calculated as the ratio of the uptake activity divided by the administered activity at the time of injection.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=25 Observations Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Maximum Uptake (%) of 177Lu-3BP-227 at Target Lesions and Discernible Organs All cycles: Body	99.7 percentage of injected 177Lu-3BP-227 Interval 99.2 to 100.0	—	—	—	—
Phase 1: Maximum Uptake (%) of 177Lu-3BP-227 at Target Lesions and Discernible Organs All cycles: Left kidney	0.247 percentage of injected 177Lu-3BP-227 Interval 0.13 to 0.409	—	—	—	—
Phase 1: Maximum Uptake (%) of 177Lu-3BP-227 at Target Lesions and Discernible Organs All cycles: Right kidney	0.227 percentage of injected 177Lu-3BP-227 Interval 0.129 to 0.452	—	—	—	—
Phase 1: Maximum Uptake (%) of 177Lu-3BP-227 at Target Lesions and Discernible Organs All cycles: Healthy liver	1.01 percentage of injected 177Lu-3BP-227 Interval 0.076 to 1.84	—	—	—	—
Phase 1: Maximum Uptake (%) of 177Lu-3BP-227 at Target Lesions and Discernible Organs All cycles: Bone marrow	1.10 percentage of injected 177Lu-3BP-227 Interval 0.56 to 1.98	—	—	—	—
Phase 1: Maximum Uptake (%) of 177Lu-3BP-227 at Target Lesions and Discernible Organs All cycles: Spleen	0.280 percentage of injected 177Lu-3BP-227 Interval 0.11 to 0.77	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The pharmacokinetic (PK) sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

Population: Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Since the study drug administered to the different groups had the same composition/specific activity, no difference in drug distribution was expected between groups and results were reported combining all groups.

The absorbed dose to the target lesions and discernible organs (i.e., organs showing uptake) was evaluated by image-based analysis. The organs considered for 177Lu-3BP-227 image-based dosimetry assessment included: healthy liver, total liver, bone marrow, left kidney, right kidney, intestine (large and small), spleen, pancreas, stomach wall, right ovary, left ovary, uterus, right testis, left testis, thymus, right thyroid gland, left thyroid gland, prostate gland and total body. The organ that had the highest absorbed dose of treatment for each participant in each treatment cycle was determined.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=14 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 1 · Right kidney	4 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 1 · Left kidney	3 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 1 · Large intestine	5 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 1 · Bladder	2 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 1 · Lymph node	0 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 2 · Large intestine	4 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 2 · Right kidney	2 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 2 · Left kidney	2 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 2 · Bladder	2 Participants	—	—	—	—
Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ Cycle 2 · Lymph node	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

Population: Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Since study drug administered to different groups had same composition/specific activity and since the specific absorbed dose is expressed relatively to the administered activity (Gray/Gbq), no difference in specific absorbed dose was expected between groups and results were reported combining all groups.

The specific absorbed dose to the target lesions was evaluated by image-based analysis. Results for all studied diseases (pancreatic ductal adenocarcinoma and colorectal carcinoma) at all anatomical locations (cervical, intrapelvic, liver, lung, lymph node, and pancreas) for all cycles (Cycle 1 and 2) are reported. The specific absorbed dose (Gray/GBq) was calculated as the absorbed dose to the target lesions (in Gray) divided by the activity of 177Lu-3BP-227 administered (in GBq).

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=47 Lesions Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Specific Absorbed Dose to the Target Lesions of 177Lu-3BP-227	0.183 Gray/GBq Interval 0.0551 to 1.21	—	—	—	—

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

The specific absorbed dose per organ was evaluated by image-based analysis. The specific absorbed dose (Gray/GBq) was calculated as the absorbed dose to an organ (in Gray) divided by the activity of 177Lu-3BP-227 administered (in GBq).

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=25 Observations of injected 177Lu-3BP-227 Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Specific Absorbed Dose Per Organ of 177Lu-3BP-227 All cycles: Bone marrow	0.0636 Gray/GBq Interval 0.0346 to 0.0943	—	—	—	—
Phase 1: Specific Absorbed Dose Per Organ of 177Lu-3BP-227 All cycles: Healthy liver	0.0515 Gray/GBq Interval 0.0263 to 0.0811	—	—	—	—
Phase 1: Specific Absorbed Dose Per Organ of 177Lu-3BP-227 All cycles: Left kidney	0.255 Gray/GBq Interval 0.102 to 1.05	—	—	—	—
Phase 1: Specific Absorbed Dose Per Organ of 177Lu-3BP-227 All cycles: Right kidney	0.242 Gray/GBq Interval 0.118 to 0.943	—	—	—	—

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

Population: Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Cumulative absorbed doses on Cycles 1 and 2 are only presented for participants who have performed the 2 cycles.

The cumulative absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated by image-based analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=1 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=3 Participants Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=3 Participants Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=3 Participants Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 Participants Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Cumulative Absorbed Organ Doses of 177Lu-3BP-227 Cycle 2: Bone marrow	0.326 Gray Interval 0.326 to 0.326	0.604 Gray Interval 0.304 to 0.645	0.680 Gray Interval 0.391 to 0.837	0.820 Gray Interval 0.628 to 1.11	0.694 Gray Interval 0.694 to 0.694
Phase 1: Cumulative Absorbed Organ Doses of 177Lu-3BP-227 Cycle 2: Healthy liver	0.254 Gray Interval 0.254 to 0.254	0.353 Gray Interval 0.271 to 0.415	0.530 Gray Interval 0.428 to 0.637	0.714 Gray Interval 0.469 to 0.927	0.571 Gray Interval 0.571 to 0.571
Phase 1: Cumulative Absorbed Organ Doses of 177Lu-3BP-227 Cycle 2: Right kidney	2.38 Gray Interval 2.38 to 2.38	3.39 Gray Interval 1.53 to 5.51	2.97 Gray Interval 2.14 to 5.74	3.01 Gray Interval 2.0 to 4.67	2.92 Gray Interval 2.92 to 2.92
Phase 1: Cumulative Absorbed Organ Doses of 177Lu-3BP-227 Cycle 2: Left kidney	2.17 Gray Interval 2.17 to 2.17	4.19 Gray Interval 1.38 to 6.21	3.33 Gray Interval 1.9 to 5.12	3.44 Gray Interval 1.9 to 3.48	2.95 Gray Interval 2.95 to 2.95

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1.

Population: Due to the early termination of the study, the PK analysis data was not collected.

The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

Population: Primary Pharmacodynamic population (for tumor response) included all participants who received at least 2 therapeutic doses of 177Lu-3BP-227 and reached the end of Cycle 2 or EOCT visit with available post-baseline tumor assessment based on RECIST 1.1 and with no major protocol deviations with an impact on the analysis.

The ORR was defined as number of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) relative to the total number of evaluable participants.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=1 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=1 Participants Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=2 Participants Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=1 Participants Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 Participants Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Number of Participants With Objective Response Rate (ORR)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

The DCR was defined as number of participants with a BOR characterized as CR, PR or stable disease according to RECIST 1.1 relative to the total number of evaluable participants.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=1 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=1 Participants Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=2 Participants Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=1 Participants Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 Participants Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Number of Participants With Disease Control Rate (DCR)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

Population: Due to the early termination of the study, survival analysis on PFS was not collected.

The PFS was defined as the time from date of first study medication administration until progression, according to RECIST 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

Population: Due to the early termination of the study, survival analysis on OS was not collected.

The OS was defined from first study medication administration until death, according to RECIST 1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks.

Population: Due to the early termination of the study, metabolic tumor response was not collected.

Tumor response assessments were planned to perform by the site investigator (local) for the phase 1 and dose escalation part and by independent reader (central) for the phase 2. All fluorine-18 fluorodeoxyglucose-PET images were used for the metabolic tumor response assessments as described in PERCIST version 1.0 by the Investigator and/or independent readers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, EOCT (maximum of 16 weeks) and early withdrawal

Population: Pharmacodynamic population included all participants who received at least 1 therapeutic dose and with available post-baseline pharmacodynamics/efficacy data.

Changes in tumor markers in serum relevant and specific to the underlying tumor disease was determined.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=2 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=3 Participants Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=5 Participants Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=3 Participants Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 Participants Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Tumor Marker Levels in Serum - Cancer Antigen 19-9 Cycle 1 Day 1	50019.00 international units/milliliter Standard Deviation 70683.81	13.00 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	20939.54 international units/milliliter Standard Deviation 46482.66	1455.50 international units/milliliter Standard Deviation 78.49	314.70 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.
Phase 1: Tumor Marker Levels in Serum - Cancer Antigen 19-9 Cycle 2 Day 1	66.00 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	456.33 international units/milliliter Standard Deviation 753.23	277.90 international units/milliliter Standard Deviation 239.71	18420.33 international units/milliliter Standard Deviation 27442.99	490.50 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.
Phase 1: Tumor Marker Levels in Serum - Cancer Antigen 19-9 EOCT	112.00 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	928.00 international units/milliliter Standard Deviation 1294.01	1166.90 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	3532.00 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	629.90 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.
Phase 1: Tumor Marker Levels in Serum - Cancer Antigen 19-9 Early Withdrawal	—	—	64.90 international units/milliliter Standard Deviation 86.41	8398.00 international units/milliliter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, EOCT (maximum of 16 weeks) and early withdrawal

Population: Pharmacodynamic population included all participants who received at least 1 therapeutic dose and with available post-baseline pharmacodynamics/efficacy data.

Changes in tumor markers in serum relevant and specific to the underlying tumor disease was determined.

Outcome measures

Outcome measures
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=2 Participants Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=3 Participants Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=5 Participants Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=3 Participants Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 Participants Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Phase 1: Tumor Marker Levels in Serum - Carcinoembryonic Antigen Cycle 1 Day 1	857.95 microgram per liter Standard Deviation 1209.22	117.40 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	112.38 microgram per liter Standard Deviation 94.41	6.65 microgram per liter Standard Deviation 7.14	3.50 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.
Phase 1: Tumor Marker Levels in Serum - Carcinoembryonic Antigen Cycle 2 Day 1	3.20 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	37.93 microgram per liter Standard Deviation 41.01	210.97 microgram per liter Standard Deviation 213.86	47.87 microgram per liter Standard Deviation 62.85	4.60 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.
Phase 1: Tumor Marker Levels in Serum - Carcinoembryonic Antigen EOCT	4.30 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	75.50 microgram per liter Standard Deviation 47.09	321.20 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	184.00 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	5.10 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.
Phase 1: Tumor Marker Levels in Serum - Carcinoembryonic Antigen Early Withdrawal	—	—	53.75 microgram per liter Standard Deviation 23.83	29.60 microgram per liter Standard Deviation NA Standard deviation cannot be calculated when only 1 participant analyzed.	—

Adverse Events

Cohort 1: 177Lu-3BP-227 2.5 GBq

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Cohort 2: 177Lu-3BP-227 4.0 GBq

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 3: 177Lu-3BP-227 5.5 GBq

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Cohort 4: 177Lu-3BP-227 6.5 GBq

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 5: 177Lu-3BP-227 7.5 GBq

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=2 participants at risk Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=3 participants at risk Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=5 participants at risk Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=3 participants at risk Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 participants at risk Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Enterocolitis	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Subileus	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders Disease progression	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	60.0% 3/5 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders General physical health deterioration	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 4 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Immune system disorders Drug hypersensitivity	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Infections and infestations Hepatic infection	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Subdural haematoma	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.

Other adverse events

Other adverse events
Measure	Cohort 1: 177Lu-3BP-227 2.5 GBq n=2 participants at risk Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 2: 177Lu-3BP-227 4.0 GBq n=3 participants at risk Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 3: 177Lu-3BP-227 5.5 GBq n=5 participants at risk Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 4: 177Lu-3BP-227 6.5 GBq n=3 participants at risk Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.	Cohort 5: 177Lu-3BP-227 7.5 GBq n=1 participants at risk Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period.
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Weight decreased	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	80.0% 4/5 • Number of events 5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	66.7% 2/3 • Number of events 7 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	66.7% 2/3 • Number of events 4 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase increased	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	66.7% 2/3 • Number of events 4 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Platelet count decreased	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Blood cholesterol increased	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Neutrophil count decreased	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations White blood cell count decreased	50.0% 1/2 • Number of events 4 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Blood bicarbonate decreased	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Blood bilirubin increased	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Blood creatinine increased	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Blood urea increased	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations C-reactive protein increased	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Haematocrit decreased	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Protein total increased	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Investigations Red blood cell count decreased	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	80.0% 4/5 • Number of events 8 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	50.0% 1/2 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypertriglyceridaemia	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypocalcaemia	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Ascites	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Ileus	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders Fatigue	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders Asthenia	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders General physical health deterioration	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders Oedema peripheral	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders Chest pain	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders Non-cardiac chest pain	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
General disorders Pyrexia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	66.7% 2/3 • Number of events 4 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	60.0% 3/5 • Number of events 6 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Psychiatric disorders Anxiety	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Psychiatric disorders Sleep disorder	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	40.0% 2/5 • Number of events 2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Psychiatric disorders Illusion	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Hepatobiliary disorders Cholestasis	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Hepatobiliary disorders Jaundice	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Renal and urinary disorders Dysuria	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Renal and urinary disorders Pollakiuria	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Renal and urinary disorders Proteinuria	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Vascular disorders Venous thrombosis	50.0% 1/2 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Infections and infestations Oral candidiasis	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Injury, poisoning and procedural complications Product prescribing error	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/2 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/3 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/5 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.	0.00% 0/1 • Treatment-emergent adverse events are reported for participants who received the therapeutic dose of 177Lu-32P-227 during the core trial (Cycle 1 Day 1 up to EOCT); maximum of 16 weeks. Safety population contained all participants who received at least 1 dose of study medication.

Additional Information

Medical Director

Ipsen Pharma SAS

Phone: see email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place