First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Epcoritamab: Administered as specified in the treatment arm.
Study summary
The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):
* The dose schedule for epcoritamab
* The side effects seen with epcoritamab
* What the body does with epcoritamab once it is administered
* What epcoritamab does to the body once it is administered
* How well epcoritamab works against relapsed and/or refractory B-cell lymphoma
The trial consists of 3 parts:
* a dose-escalation part (Phase 1, first-in-human \[FIH\])
* an expansion part (Phase 2a)
* a dose-optimization part (OPT) (Phase 2a)
The trial time for each participant depends on which trial part the participant enters:
* For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
* For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.
All participants will receive active drug, and no participants will be given placebo.
Eligibility
Primary outcome measure(s)
- Dose-Escalation: Dose Limiting Toxicity (DLT) — During the first cycle (28 days)
To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. - Dose-Escalation: Number of Participants with Adverse Events (AEs) — From first dose until the end of the safety follow-up period (Up to 1 year)
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 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. - Expansion: Overall Response Rate (ORR) — Up to 1.5 years
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria. - Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events — From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)
CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Trial sites (85)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Mayo Clinic | Phoenix | Arizona | |
| University of California at San Francisco | San Francisco | California | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | |
| Ochsner Medical Center | New Orleans | Louisiana | |
| University of Michigan | Ann Arbor | Michigan | |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | |
| University of Nebraska Medical Center | Omaha | Nebraska | |
| Hackensack Meridian Health | Hackensack | New Jersey | |
| The Cleveland Clinic Foundation | Cleveland | Ohio | |
| OHSU Knight Cancer Institute | Portland | Oregon | |
| Hillman Cancer Center | Pittsburgh | Pennsylvania | |
| Rhode Island Hospital | Providence | Rhode Island | |
| Medical University of South Carolina | Charleston | South Carolina | |
| UT Southwestern | Dallas | Texas | |
| MD Anderson Cancer Center | Houston | Texas | |
| Monash Health | Clayton | Australia | |
| Concord Hospital | Concord | Australia | |
| St. Vincent Hospital | Fitzroy | Australia | |
| Royal Brisbane and Women's Hospital | Herston | Australia | |
| Royal Hobart Hospital RHH | Hobart | Australia | |
| St. George Hospital | Kogarah | Australia | |
| Cabrini Hospital | Malvern | Australia | |
| Sir Charles Gairdner Hospital | Nedlands | Australia | |
| Gold Coast Hospital | Southport | Australia | |
| Westmead Hospital | Sydney | Australia | |
| Tom Baker Cancer Care | Calgary | Canada | |
| Toronto-Sunnybrook Regional Cancer Ctr | Toronto | Canada | |
| Rigshospitalet | Copenhagen | Denmark | |
| Odense University Hospital | Odense | Denmark | |
| Vejle Hospital | Vejle | Denmark | |
| Helsinki University Hospital | Helsinki | Finland | |
| Kuopio University Hospital | Kuopio | Finland | |
| Tampere University Hospital | Tampere | Finland | |
| Hopital Henri Mondor | Créteil | France | |
| CHU Montpellier | Montpellier | France | |
| Hospital Saint-Louis | Paris | France | |
| Hospices Civils de Lyon Centre Hospitalier Lyon Sud | Pierre-Bénite | France | |
| Centre Henri Becquerel | Rouen | France |
+ 45 more sites — see the full list on the official registry below.
More Genmab trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03625037 on ClinicalTrials.gov ↗ ← All trials in Spain