Trial Outcomes & Findings for A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma (NCT NCT06018129)
NCT ID: NCT06018129
Last Updated: 2025-09-25
Results Overview
A DLT was defined as any of the following toxicities except those that were clearly due to the underlying disease or extraneous cause: all Grade 5 toxicities, hematological toxicities (Grade 4 neutropenia, Grade 3 and Grade 4 febrile neutropenia lasting \>2 days, Grade 4 thrombocytopenia of any duration with clinically significant bleeding or ≥ Grade 3 thrombocytopenia requiring platelet transfusion, Grade 4 anemia), non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\] per American Society for Transplantation and Cellular Therapy \[ASTCT\] criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, Grade 4 immune effector cell-associated neurotoxicity syndrome \[ICANS\] according to ASTCT criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, tumor lysis syndrome \[TLS\] Grade 4 or Grade 3 unresolved within 5 days, any ≥ Grade 3 \[severe or life-threatening\] non-hematological toxicities \[with exceptions\]).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
21 days
Results posted on
2025-09-25
Participant Flow
This trial was conducted in participants with classical Hodgkin lymphoma and T-cell lymphoma. This trial was planned to be conducted in 2 parts: dose escalation and expansion; however, it was terminated during dose escalation and did not proceed to expansion.
Participant milestones
| Measure |
GEN3017 Medium Priming Dose + Low Full Dose
Participants received GEN3017 at a medium priming dose and a low full dose.
|
GEN3017 High Priming Dose + High Full Dose
Participants received GEN3017 at a high priming dose and a high full dose.
|
GEN3017 Low Priming Dose + High Full Dose
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
Received At Least 1 Dose of Trial Treatment
|
3
|
3
|
3
|
|
Overall Study
Number of Participants Enrolled With Classical Hodgkin Lymphoma
|
1
|
3
|
0
|
|
Overall Study
Number of Participants Enrolled With T-cell Lymphoma
|
2
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
GEN3017 Medium Priming Dose + Low Full Dose
Participants received GEN3017 at a medium priming dose and a low full dose.
|
GEN3017 High Priming Dose + High Full Dose
Participants received GEN3017 at a high priming dose and a high full dose.
|
GEN3017 Low Priming Dose + High Full Dose
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
2
|
|
Overall Study
Sponsor Decision
|
2
|
2
|
1
|
Baseline Characteristics
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
n=99 Participants
|
62.0 years
STANDARD_DEVIATION 17.3 • n=107 Participants
|
40.0 years
STANDARD_DEVIATION 19.8 • n=206 Participants
|
56.0 years
STANDARD_DEVIATION 27.9 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 20.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Malay
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Measured in the Dose-Determining Set, which included all participants from the Safety Set who met the minimum exposure criteria and had either completed the DLT observation period or had experienced a DLT during the specified time period.
A DLT was defined as any of the following toxicities except those that were clearly due to the underlying disease or extraneous cause: all Grade 5 toxicities, hematological toxicities (Grade 4 neutropenia, Grade 3 and Grade 4 febrile neutropenia lasting \>2 days, Grade 4 thrombocytopenia of any duration with clinically significant bleeding or ≥ Grade 3 thrombocytopenia requiring platelet transfusion, Grade 4 anemia), non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\] per American Society for Transplantation and Cellular Therapy \[ASTCT\] criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, Grade 4 immune effector cell-associated neurotoxicity syndrome \[ICANS\] according to ASTCT criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, tumor lysis syndrome \[TLS\] Grade 4 or Grade 3 unresolved within 5 days, any ≥ Grade 3 \[severe or life-threatening\] non-hematological toxicities \[with exceptions\]).
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 1 year 2 monthsPopulation: Measured in the Safety Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
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 was therefore 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.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Number of Participants With Adverse Events (AEs)
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: Measured in the Pharmacokinetic (PK) Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017
Day 1
|
0.0064 micrograms per milliliter (ug/mL)
|
0.0449 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 30.4032
|
0.0025 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 148.0402
|
0.0005 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation (Geo CV%) could not be calculated because all reported values were identical, resulting in a geometric standard deviation of 1. As a consequence, the Geo CV% could not be calculated.
|
|
Dose Escalation Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017
Day 8
|
0.0389 micrograms per milliliter (ug/mL)
|
0.2503 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 15.7057
|
0.0056 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 142.6003
|
0.0063 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 33.1330
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: Measured in the PK Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Time to Reach Cmax (Tmax) of GEN3017
Day 1
|
2.6069 days
|
6.6736 days
Geometric Coefficient of Variation 164.5774
|
1.6424 days
Geometric Coefficient of Variation 95.0650
|
0.2322 days
Geometric Coefficient of Variation 0.9590
|
|
Dose Escalation Part: Time to Reach Cmax (Tmax) of GEN3017
Day 8
|
3.0340 days
|
3.8858 days
Geometric Coefficient of Variation 51.7969
|
2.2907 days
Geometric Coefficient of Variation 18.1691
|
2.0079 days
Geometric Coefficient of Variation 75.6204
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: Measured in the PK Analysis Set, which included all participants who received at least 1 dose of GEN3017 and provided at least 1 evaluable PK sample. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017
Day 1
|
0.0375 day*ug/mL
|
0.3642 day*ug/mL
Geometric Coefficient of Variation 56.7248
|
0.0122 day*ug/mL
Geometric Coefficient of Variation 132.1774
|
0.0034 day*ug/mL
Geometric Coefficient of Variation 2.2752
|
|
Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017
Day 8
|
0.1798 day*ug/mL
|
1.2989 day*ug/mL
Geometric Coefficient of Variation 22.6968
|
0.0282 day*ug/mL
Geometric Coefficient of Variation 160.8826
|
0.0304 day*ug/mL
Geometric Coefficient of Variation 30.4785
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: While blood samples were collected to derive data for this planned PK outcome measure, the study was terminated prior to that data being generated, analyzed, summarized, or made available by the study sponsor. Therefore, no PK data can be presented here. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected.
Venous blood samples were collected for analyzing concentrations of GEN3017.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 1 year 2 monthsPopulation: Measured in the Immunogenicity Analysis Set, which included all participants who received at least 1 dose of GEN3017 and had a baseline and at least 1 evaluable on-treatment ADA sample. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.
Venous blood samples were drawn for analysis of ADAs in serum samples.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Number of Participants With Anti-drug Antibodies (ADAs) to GEN3017
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 1 year 2 monthsPopulation: Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.
ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) based on the Lugano criteria as assessed by investigator. All other categories, including not evaluable, were considered non-response. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and 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 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Data are presented for the number of participants with ORR.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 Participants
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Objective Response Rate (ORR)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 1 year 2 monthsPopulation: Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017, in participants who achieved a response. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.
DOR was defined as the time from the first documentation of response (CR or PR) to the date of progressive disease or death, whichever occurred earlier based on the Lugano criteria as assessed by investigator.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=1 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Duration of Response (DOR)
|
—
|
2.23 months
Data could not be calculated as there was only 1 participant with a response.
|
4.17 months
Data could not be calculated as there was only 1 participant with a response.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 1 year 2 monthsPopulation: Measured in the FAS, which included participants enrolled and treated with at least 1 dose of GEN3017, in participants who achieved a response. As pre-specified, data were collected and are reported per Classical Hodgkin Lymphoma and T cell Lymphoma groups. The trial was terminated prior to the start of the expansion part. Therefore, no data for the expansion part were collected and data were collected and are reported for the dose escalation part only.
TTR was defined as the time from Day 1 to first documentation of objective response (CR or PR) in participants achieving PR or CR based on the Lugano criteria as assessed by investigator.
Outcome measures
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=1 Participants
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 Participants
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Dose Escalation Part: Time to Response (TTR)
|
—
|
1.18 months
Standard Deviation NA
Data could not be calculated as there was only 1 participant with a response.
|
1.25 months
Standard Deviation NA
Data could not be calculated as there was only 1 participant with a response.
|
—
|
Adverse Events
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 participants at risk
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 participants at risk
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 participants at risk
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 participants at risk
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
100.0%
2/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
Other adverse events
| Measure |
Classical Hodgkin Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=1 participants at risk
Participants received GEN3017 at a medium priming dose and a low full dose.
|
Classical Hodgkin Lymphoma: GEN3017 High Priming Dose + High Full Dose
n=3 participants at risk
Participants received GEN3017 at a high priming dose and a high full dose.
|
T-cell Lymphoma: GEN3017 Medium Priming Dose + Low Full Dose
n=2 participants at risk
Participants received GEN3017 at a medium priming dose and a low full dose.
|
T-cell Lymphoma: GEN3017 Low Priming Dose + High Full Dose
n=3 participants at risk
Participants received GEN3017 at a low priming dose and a high full dose.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
General disorders
Chest discomfort
|
100.0%
1/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
1/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Investigations
Strongyloides test positive
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
100.0%
2/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
General disorders
Injection site reaction
|
100.0%
1/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
66.7%
2/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
100.0%
2/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
66.7%
2/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
66.7%
2/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
66.7%
2/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
66.7%
2/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
33.3%
1/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/1 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
50.0%
1/2 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
0.00%
0/3 • Up to approximately 1 year 2 months
Measured in the Safety Analysis Set, which included participants enrolled and treated with at least 1 dose of GEN3017.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place