Trial Outcomes & Findings for Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy (NCT NCT06391775)
NCT ID: NCT06391775
Last Updated: 2026-08-11
Results Overview
An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to approximately 1.5 years
Results posted on
2026-08-11
Participant Flow
This trial was terminated early due to a strategic decision. Only the GEN1055 monotherapy dose escalation part was initiated. The dose escalation with GEN1055 in combination with a fixed dose of pembrolizumab and the dose expansion parts were not initiated.
Participant milestones
| Measure |
GEN1055 10 mg
Participants received GEN1055 at a dose of 10 milligrams (mg) via an intravenous (IV) infusion every 3 weeks (Q3W).
|
GEN1055 30 mg
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
GEN1055 200 mg
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
6
|
|
Overall Study
Received at Least One Dose of Treatment
|
3
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
6
|
6
|
Reasons for withdrawal
| Measure |
GEN1055 10 mg
Participants received GEN1055 at a dose of 10 milligrams (mg) via an intravenous (IV) infusion every 3 weeks (Q3W).
|
GEN1055 30 mg
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
GEN1055 200 mg
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
4
|
2
|
|
Overall Study
Lost to Follow-Up
|
1
|
1
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Study Early Terminated
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy
Baseline characteristics by cohort
| Measure |
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
12 Participants
n=161 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
9 Participants
n=161 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 10 • n=54 Participants
|
57 years
STANDARD_DEVIATION 12 • n=54 Participants
|
62.3 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
56.2 years
STANDARD_DEVIATION 12.3 • n=26 Participants
|
58.1 years
STANDARD_DEVIATION 10.6 • n=161 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=26 Participants
|
15 Participants
n=161 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
6 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=161 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=26 Participants
|
19 Participants
n=161 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=54 Participants
|
5 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=26 Participants
|
19 Participants
n=161 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=161 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: Safety analysis set included participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Number of Participants With Adverse Events (AEs)
|
6 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety analysis set included participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
A DLT was defined as any of the following events during the DLT evaluation period (21 days). All grade 5 events, anaphylaxis, grade ≥3 infusion-related reaction (IRR), hematological events (grade 4 neutropenia lasting more than 7 days, grade 4 thrombocytopenia for ≥7 consecutive days, grade 3/4 febrile neutropenia for more than 1 hour, grade 3/4 hemorrhage associated with thrombocytopenia of ≥ grade 3 requiring platelet transfusion, grade 4 anemia), nonhematological events (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] elevations ≥ grade 2 with concomitant bilirubin \>2.0×upper limit of normal \[ULN\] with no signs of cholestasis and no other reason can be found to explain the combination of increased ALT/AST and total bilirubin, ie, a Hy's law case, all nonhematological toxicities of grade ≥3 (severe or life-threatening), with exclusions per protocol). Toxicities were graded for severity according to National Cancer Institute Common Terminology Criteria
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2 (cycles were 21 days)Population: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of GEN1055 and who provided at least 1 evaluable PK sample for GEN1055. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = number of participants evaluable at the specified timepoint.
Blood samples were collected and processed to obtain plasma to evaluate the pharmacokinetics (PK) of GEN1055.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Maximum (Peak) Plasma Concentration (Cmax) of GEN1055
Cycle 1
|
72.261 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 9.985
|
3.048 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 23.681
|
9.726 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 32.352
|
33.630 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 18.501
|
|
Dose Escalation: Maximum (Peak) Plasma Concentration (Cmax) of GEN1055
Cycle 2
|
54.541 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 40.394
|
0.655 micrograms per milliliter (ug/mL)
|
2.457 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 111.068
|
17.902 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 70.874
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2 (cycles were 21 days)Population: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of GEN1055 and who provided at least 1 evaluable PK sample for GEN1055. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = number evaluable at the specified timepoint.
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Time to Reach Cmax (Tmax) for GEN1055
Cycle 1
|
0.0632 days
Geometric Coefficient of Variation 101.9597
|
0.1396 days
Geometric Coefficient of Variation 21.6112
|
0.0653 days
Geometric Coefficient of Variation 55.0471
|
0.1554 days
Geometric Coefficient of Variation 55.3309
|
|
Dose Escalation: Time to Reach Cmax (Tmax) for GEN1055
Cycle 2
|
0.0814 days
Geometric Coefficient of Variation 56.5632
|
0.0420 days
|
0.0603 days
Geometric Coefficient of Variation 61.8987
|
0.1253 days
Geometric Coefficient of Variation 66.9736
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2 (cycles were 21 days)Population: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of GEN1055 and who provided at least 1 evaluable PK sample for GEN1055. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = number evaluable at the specified timepoint.
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Outcome measures
| Measure |
GEN1055 200 mg
n=4 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=1 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=3 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Plasma Trough (Pre-dose) Concentrations (Ctrough) of GEN1055
Cycle 1
|
1.5348 ug/mL
Geometric Coefficient of Variation 165.4359
|
—
|
1.4300 ug/mL
|
1.7278 ug/mL
Geometric Coefficient of Variation 73.0282
|
|
Dose Escalation: Plasma Trough (Pre-dose) Concentrations (Ctrough) of GEN1055
Cycle 2
|
2.4876 ug/mL
Geometric Coefficient of Variation 80.7455
|
—
|
—
|
0.7643 ug/mL
Geometric Coefficient of Variation 123.6314
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2 (cycles were 21 days)Population: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of GEN1055 and who provided at least 1 evaluable PK sample for GEN1055. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = number evaluable at the specified timepoint.
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-tlast) for GEN1055
Cycle 1
|
523.68 ug*day/mL
Geometric Coefficient of Variation 22.00
|
12.80 ug*day/mL
Geometric Coefficient of Variation 14.68
|
48.86 ug*day/mL
Geometric Coefficient of Variation 40.76
|
235.07 ug*day/mL
Geometric Coefficient of Variation 22.15
|
|
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-tlast) for GEN1055
Cycle 2
|
174.79 ug*day/mL
Geometric Coefficient of Variation 98.59
|
0.45 ug*day/mL
|
2.22 ug*day/mL
Geometric Coefficient of Variation 165.18
|
24.80 ug*day/mL
Geometric Coefficient of Variation 102.90
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2 (cycles were 21 days)Population: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of GEN1055 and who provided at least 1 evaluable PK sample for GEN1055. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = number evaluable at the specified timepoint.
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=5 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) for GEN1055
Cycle 1
|
564.55 ug*day/mL
Geometric Coefficient of Variation 36.20
|
15.84 ug*day/mL
Geometric Coefficient of Variation 21.73
|
97.19 ug*day/mL
Geometric Coefficient of Variation 123.82
|
290.81 ug*day/mL
Geometric Coefficient of Variation 17.08
|
|
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) for GEN1055
Cycle 2
|
183.32 ug*day/mL
Geometric Coefficient of Variation 98.20
|
0.80 ug*day/mL
|
13.91 ug*day/mL
Geometric Coefficient of Variation 135.36
|
209.37 ug*day/mL
Geometric Coefficient of Variation 45.30
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2 (cycles were 21 days)Population: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of GEN1055 and who provided at least 1 evaluable PK sample for GEN1055. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = number evaluable at the specified timepoint.
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=5 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Half-life (t½) of GEN1055
Cycle 2
|
2.690 days
Geometric Coefficient of Variation 65.802
|
0.867 days
|
2.304 days
Geometric Coefficient of Variation 128.510
|
4.331 days
Geometric Coefficient of Variation 45.430
|
|
Dose Escalation: Half-life (t½) of GEN1055
Cycle 1
|
3.284 days
Geometric Coefficient of Variation 104.802
|
3.662 days
Geometric Coefficient of Variation 7.022
|
8.739 days
Geometric Coefficient of Variation 69.909
|
6.051 days
Geometric Coefficient of Variation 29.437
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2 (cycles were 21 days)Population: Pharmacokinetic Analysis Set included all participants who received at least 1 dose of GEN1055 and who provided at least 1 evaluable PK sample for GEN1055. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = number evaluable at the specified timepoint.
Blood samples were collected and processed to obtain plasma to evaluate the PK of GEN1055.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=5 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Clearance (CL) of GEN1055 From the Plasma
Cycle 1
|
382.8 mL/day
Geometric Coefficient of Variation 24.2
|
642.9 mL/day
Geometric Coefficient of Variation 19.9
|
402.3 mL/day
Geometric Coefficient of Variation 37.1
|
385.2 mL/day
Geometric Coefficient of Variation 13.9
|
|
Dose Escalation: Clearance (CL) of GEN1055 From the Plasma
Cycle 2
|
1123.3 mL/day
Geometric Coefficient of Variation 102.7
|
12518.1 mL/day
|
2456.6 mL/day
Geometric Coefficient of Variation 133.6
|
500.6 mL/day
Geometric Coefficient of Variation 56.5
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: Immunogenicity analysis set included all participants who received at least 1 dose of GEN1055 and had a baseline and at least 1 evaluable on-treatment ADA sample.
Venous blood samples were drawn for analysis of ADAs.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Number of Participants With Anti-Drug Antibodies (ADA)
|
5 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: Response evaluable set included all participants who had baseline evaluable disease according to RECIST v1.1 and at least 1 postbaseline disease assessment. It also included participants who died or were withdrawn from treatment due to clinical progression before the first response assessment; these participants were treated as non-responders.
ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as assessed by investigator. CR was defined as disappearance of all target and non-target tumor lesions, reduction in short axis to \<10 millimeters (mm) in all pathological target and non-target lymph nodes and normalization of tumor marker level (if applicable). PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=5 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Overall Response Rate (ORR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: Response evaluable set included all participants who had baseline evaluable disease according to RECIST v1.1 and at least 1 postbaseline disease assessment. It also included participants who died or were withdrawn from treatment due to clinical progression before the first response assessment; these participants were treated as non-responders. Overall number of participants analyzed = participants with a response (CR or PR).
DOR based on investigator assessment was defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurred earlier according to RECIST v1.1. CR was defined as disappearance of all target and non-target tumor lesions, reduction in short axis to \<10 mm in all pathological target and non-target lymph nodes and normalization of tumor marker level (if applicable). PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 1 of the following: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of ≥5 mm in the sum of diameters, or unequivocal appearance of 1 or more new lesion(s), or unequivocal progression of non-target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: Response evaluable set included all participants who had baseline evaluable disease according to RECIST v1.1 and at least 1 postbaseline disease assessment. It also included participants who died or were withdrawn from treatment due to clinical progression before the first response assessment; these participants were treated as non-responders. Overall number of participants analyzed = participants with a response (CR or PR).
TTR based on investigator assessment was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of objective response (CR or PR) in participants achieving PR or CR according to RECIST v1.1. CR was defined as disappearance of all target and non-target tumor lesions, reduction in short axis to \<10 mm in all pathological target and non-target lymph nodes and normalization of tumor marker level (if applicable). PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 1.5 yearsPopulation: Response evaluable set included all participants who had baseline evaluable disease according to RECIST v1.1 and at least 1 postbaseline disease assessment. It also included participants who died or were withdrawn from treatment due to clinical progression before the first response assessment; these participants were treated as non-responders.
DCR was defined as the percentage of participants with BOR of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by investigator. CR was defined as disappearance of all target and non-target tumor lesions, reduction in short axis to \<10 mm in all pathological target and non-target lymph nodes and normalization of tumor marker level (if applicable). PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters (nadir) while on trial.
Outcome measures
| Measure |
GEN1055 200 mg
n=6 Participants
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
GEN1055 10 mg
n=3 Participants
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=5 Participants
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 Participants
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Dose Escalation: Disease Control Rate (DCR)
|
33 percentage of participants
Interval 4.3 to 77.7
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 52.2
|
50 percentage of participants
Interval 11.8 to 88.2
|
Adverse Events
GEN1055 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
GEN1055 30 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths
GEN1055 100 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
GEN1055 200 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
GEN1055 10 mg
n=3 participants at risk
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 participants at risk
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 participants at risk
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
GEN1055 200 mg
n=6 participants at risk
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Infections and infestations
Meningoencephalitis viral
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
Other adverse events
| Measure |
GEN1055 10 mg
n=3 participants at risk
Participants received GEN1055 at a dose of 10 mg via an IV infusion Q3W.
|
GEN1055 30 mg
n=6 participants at risk
Participants received GEN1055 at a dose of 30 mg via an IV infusion Q3W.
|
GEN1055 100 mg
n=6 participants at risk
Participants received GEN1055 at a dose of 100 mg via an IV infusion Q3W.
|
GEN1055 200 mg
n=6 participants at risk
Participants received GEN1055 at a dose of 200 mg via an IV infusion Q3W.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Infections and infestations
Covid-19
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
50.0%
3/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
General disorders and administration site conditions
Pain
|
66.7%
2/3 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
General disorders and administration site conditions
Face oedema
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 4 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
General disorders and administration site conditions
Fatigue
|
66.7%
2/3 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 7 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
50.0%
3/6 • Number of events 3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
33.3%
2/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 2 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
0.00%
0/6 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
16.7%
1/6 • Number of events 1 • Up to approximately 1.5 years
Safety analysis set included all participants enrolled and treated with at least 1 dose of GEN1055. Participants were analyzed according to actual treatment (dose level).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place