Trial · NCT04358458
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
NCT04358458, Phase 1, Phase 2, Terminated, Genmab; results first posted 2024-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas. Trials, record NCT04358458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04358458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
- NCT number
- NCT04358458
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Genmab
- Conditions
Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, High-grade B-cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma
- Interventions
- GEN3009, Epcoritamab
- First posted
- 2020-04-24
- Last updated
- 2024-10-24
- Other registries' IDs
- eudract:2019-002752-16
- Results first posted
- 2024-08-13
- Limitations and caveats
- The trial was terminated due to strategic evaluation of GEN3009 within context of Genmab's portfolio, decision not based on any safety or regulatory concerns.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | During the first treatment cycle (Cycle length=28 days) | DLTs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, except for TLS (Cairo-Bishop grading) and CRS/ICANS (Lee et al., 2019). These criteria include: all Grade 5 toxicities; hematologic events including thrombocytopenia Grade 4, neutropenia Grade 4, Febrile neutropenia Grade 3 or 4, Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3, anemia of Grade 4 and tumor lysis syndrome (TLS) Grade 4; and non-hematologic AEs of Grade 3 or higher excluding certain fevers, hypotension, laboratory values, Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), nausea, vomiting, diarrhea, fatigue/asthenia, or alopecia (no grading), which meet certain additional criteria. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose until 30 days after the last dose (up to 15.5 months) | An AE is 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 SAE is defined as an AE that meets one of the following criteria: is fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is "medically significant"\]); required inpatient hospitalization or prolongation of existing hospitalization. TEAEs are defined as AEs which begin, or worsen, during the on-treatment period ending 4 weeks after the last dose of study medication. |
| Primary | Number of Participants With AEs of Special Interest (AESI) | From first dose until 30 days after the last dose (up to 15.5 months) | AESIs are defined as events (serious or non-serious) that are of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs | From first dose until 30 days after the last dose (up to 15.5 months) | Laboratory parameters included hematology, serum chemistries and urinalysis. Clinically significant laboratory abnormalities were based upon the Investigator's discretion. Laboratory parameters captured as AEs are reported in this outcome measure. |
| Primary | Number of Participants With Clinically Notable Vital Signs | From first dose up to end of treatment (up to 14.5 months) | Criteria for clinically notable (elevated and below normal values respectively) vital signs are as follows: Systolic Blood Pressure (SBP): ≥180 millimeters of mercury (mmHg) and an increase ≥20 mmHg from baseline, ≤90 mmHg and a decrease ≥20 mmHg from baseline; Diastolic Blood Pressure (DBP): ≥105 mmHg and an increase ≥15 mmHg from baseline, ≤50 mmHg and a decrease ≥15 mmHg from baseline; Heart rate: ≥120 beats per minute (bpm) with an increase of ≥15 bpm from baseline, ≤50 bpm and a decrease ≥15 bpm from baseline; Temperature: \> 38 degree Celsius (°C) and \< 35°C. Number of participants with clinically notable elevated and below normal vital signs values up to end of treatment are reported. |
| Primary | Number of Participants With Dose Delays and Dose Interruptions | From first dose until 30 days after the last dose (up to 15.5 months) | Number of participants with dose delays and dose Interruptions due to AE, Coronavirus disease 2019 (COVID-19), drug administration issues and other unspecified reasons are reported. |
| Primary | Actual Dose Intensity | From first dose until 30 days after the last dose (up to 15.5 months) | Actual dose intensity (milligrams per cycle \[mg/cycle\]) is calculated as cumulative dose/number of cycles initiated. |
| Secondary | Apparent Total Plasma Clearance (CL) of GEN3009 | Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 hours (h) and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days) | |
| Secondary | Volume of Distribution of GEN3009 | Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days) | |
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Day 7 of GEN3009 | Pre-dose and 5 minutes post-dose on days 1, 2 and 4 (S2 only); 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days) |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) | During the first treatment cycle (Cycle length=28 days) | The Safety analysis set included all participants who had received at least 1 dose of GEN3009. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose until 30 days after the last dose (up to 15.5 months) | The Safety analysis set included all participants who had received at least 1 dose of GEN3009. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs of Special Interest (AESI) | From first dose until 30 days after the last dose (up to 15.5 months) | The Safety analysis set included all participants who had received at least 1 dose of GEN3009. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities Reported as TEAEs | From first dose until 30 days after the last dose (up to 15.5 months) | The Safety analysis set included all participants who had received at least 1 dose of GEN3009. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Notable Vital Signs | From first dose up to end of treatment (up to 14.5 months) | The Safety analysis set included all participants who had received at least 1 dose of GEN3009. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Delays and Dose Interruptions | From first dose until 30 days after the last dose (up to 15.5 months) | The Safety analysis set included all participants who had received at least 1 dose of GEN3009. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Actual Dose Intensity | From first dose until 30 days after the last dose (up to 15.5 months) | The Safety analysis set included all participants who had received at least 1 dose of GEN3009. 'Number analyzed' indicates the number of participants with data available for analysis at specified cycle duration. | mg/cycle | MEAN |
| SECONDARY | Apparent Total Plasma Clearance (CL) of GEN3009 | Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2 hours (h) and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days) | The pharmacokinetic analysis set (PAS) includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. | Liters per day | MEAN |
| SECONDARY | Volume of Distribution of GEN3009 | Pre-dose and 5 minutes post-dose on days 1, 2, 4 (S2 only), 8, 15, 22 and 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days) | The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. | mL | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Day 7 of GEN3009 | Pre-dose and 5 minutes post-dose on days 1, 2 and 4 (S2 only); 2h and 4h post-dose on days 1 and 2, 24h post-dose on day 2 and 72h post-dose on day 4 of Cycles 1 and 2 (Each cycle length=28 days) | The PAS includes all participants who have been exposed to GEN3009 and have had at least one pharmacokinetic sample collected that has provided a valid bioanalytical result. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at a specified cycle. | micrograms*day per milliliter(ug*day/mL) | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group390
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level A in S1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level B in S1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level C in S1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level D in S1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level D in S2 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level E in S1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level F in S1 | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Part 1: GEN3009 Dose Level G in S1 | 3 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Part 1: GEN3009 Dose Level A in S1 | Participants with TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Part 1: GEN3009 Dose Level B in S1 | Participants with TEAEs | 4 | Participants |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: GEN3009 Dose Level A in Schedule 1 (S1) | 3 | |
| Overall Study | STARTED | Part 1: GEN3009 Dose Level B in S1 | 4 | |
| Overall Study | STARTED | Part 1: GEN3009 Dose Level C in S1 | 7 | |
| Overall Study | STARTED | Part 1: GEN3009 Dose Level D in S1 | 10 | |
| Overall Study | STARTED | Part 1: GEN3009 Dose Level D in Schedule (S2) | 3 | |
| Overall Study | STARTED | Part 1: GEN3009 Dose Level E in S1 | 10 | |
| Overall Study | STARTED | Part 1: GEN3009 Dose Level F in S1 | 3 | |
| Overall Study | STARTED | Part 1: GEN3009 Dose Level G in S1 | 6 | |
| Overall Study | COMPLETED | Part 1: GEN3009 Dose Level A in Schedule 1 (S1) | 0 | |
| Overall Study | COMPLETED | Part 1: GEN3009 Dose Level B in S1 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,408
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level A in S1 | 0 | 3 | |
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level B in S1 | 0 | 4 | |
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level C in S1 | 0 | 7 | |
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level D in S1 | 1 | 10 | |
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level D in S2 | 0 | 3 | |
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level E in S1 | 0 | 10 | |
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level F in S1 | 0 | 3 | |
| other | Groin pain | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level G in S1 | 0 | 6 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level A in S1 | 0 | 3 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 1: GEN3009 Dose Level B in S1 | 0 | 4 |
1 to 10 of 1,408Source ClinicalTrials.gov
See all 1,408 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: GEN3009 Dose Level A in S1 | 1 | 3 |
| Total, all-cause mortality | Part 1: GEN3009 Dose Level B in S1 | 1 | 4 |
| Total, all-cause mortality | Part 1: GEN3009 Dose Level C in S1 | 3 | 7 |
| Total, all-cause mortality | Part 1: GEN3009 Dose Level D in S1 | 8 | 10 |
| Total, all-cause mortality | Part 1: GEN3009 Dose Level D in S2 | 1 | 3 |
| Total, all-cause mortality | Part 1: GEN3009 Dose Level E in S1 | 6 | 10 |
| Total, all-cause mortality | Part 1: GEN3009 Dose Level F in S1 | 2 | 3 |
| Total, all-cause mortality | Part 1: GEN3009 Dose Level G in S1 | 3 | 6 |
| Total, other adverse events | Part 1: GEN3009 Dose Level A in S1 | 3 | 3 |
| Total, other adverse events | Part 1: GEN3009 Dose Level B in S1 | 4 | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04358458
GET https://conductscience.org/api/trials/v1/NCT04358458/registered?page=2