First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Study Identifier
GCT3013-01
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
2023-504802-12-00
For general inquiries, please contact
Recruitment Complete
Study Details
Medical Condition
Study Drug
Phase
Phase 1/Phase 2
Sex
Female & Male
Age
18+ years
Protocol 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.
Study Locations
Location
Status
Location
Arizona Mayo Clinic
Phoenix, Arizona, United States, 85054
Status
Not applicable
Location
University of California at San Francisco
San Francisco, California, United States, 94117
Status
Not applicable
Location
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Status
Not applicable
Location
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Status
Not applicable
Location
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Status
Not applicable
Location
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Status
Not applicable
Showing {first} - {last} of {total} Results