Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
a study on Diffuse Large B-Cell Lymphoma Lymphoma Non-Hodgkin Lymphoma Hodgkin's Lymphoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA UCSF
- Dates
- study startedestimated completion
Description
Summary
A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents in subjects with B-cell Non-Hodgkin Lymphoma (B-NHL).
Official Title
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Details
All participants in the trial will receive epcoritamab, as monotherapy or in combination. The following regimens will be investigated:
- Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with previously untreated diffuse large B-cell lymphoma (DLBCL)
- Arm 2: epcoritamab + rituximab and lenalidomide (R2) in subjects with relapsed/refractory (R/R) follicular lymphoma (FL)
- Arm 3: epcoritamab + rituximab and bendamustine (BR) in subjects with previously untreated FL
- Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in subjects with R/R DLBCL eligible for autologous stem cell transplant (ASCT)
- Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in subjects with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity
- Arm 6: epcoritamab + R2 in subjects with previously untreated FL
- Arm 7: epcoritamab maintenance in subjects with FL who achieve a complete response (CR) or a partial response (PR) with SOC treatment
- Arm 8: epcoritamab + reduced dose of R-CHOP (R mini-CHOP) in subjects with previously untreated DLBCL who are ineligible to receive full-dose anthracycline
The trial consists of two parts: Part 1 ('Dose Escalation') and Part 2 ('Dose Expansion'). The primary objective of Part 1 is safety, and it includes Arm 1-5. Part 2 includes all 8 arms (Arm 1-8) and the primary goal of all arms, except Arm 7, is preliminary efficacy. For Arm 7, the primary goal is safety. Patients in Arm 1-5 can only participate in either Part 1 or Part 2. Dose Limiting Toxicities (DLTs) will be assessed in Part 1 and for a selected number of patients in Arm 8 during a 28-day period ('safety-run phase'). The arms are conducted in parallel.
Keywords
Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, DuoBody®, monoclonal antibodies, anti-CD3, anti-CD20, Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Gemcitabine, Cytarabine, Dexamethasone, Prednisone, Cyclophosphamide, Bendamustine Hydrochloride, Rituximab, Carboplatin, Doxorubicin, Liposomal doxorubicin, Oxaliplatin, Vincristine, Lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide, rituximab and bendamustine, rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin, gemcitabine and oxaliplatin, Epcoritamab, Epcoritamab Maintenance, rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone, Epcoritamab + R-CHOP, Epcoritamab + R2, Epcoritamab + BR, Epcoritamab + R-DHAX/C, Epcoritamab + GemOx, Epcoritamab + R mini-CHOP
Eligibility
You can join if…
Open to people ages 18 years and up
- Subject must sign an Informed Consent Form (ICF)
- At least 18 years of age
- Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
- Acceptable organ function at screening
- CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
- If of childbearing potential subject must practicing a highly effective method of birth control
- A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
Arm 1:
- Newly Diagnosed Documented diffuse large B-cell lymphoma (DLBCL)
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 2: R/R FL
Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
Arm 4:
- Documented DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 5:
- Relapsed or refractory documented DLBCL and ineligible for HDT-ASCT
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
- FL Grade 3B
Arm 6: Newly diagnosed, previously untreated FL grade 1-3A
Arm 7:
- FL Grade 1-3A
- If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.
Arm 8:
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- "double-hit" or "triple-hit" DLBCL
- FL Grade 3B
You CAN'T join if...
- Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
- Any prior treatment with a bispecific antibody targeting CD3 and CD20.
- Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
- Clinically significant cardiovascular disease
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
- Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- Known history of seropositivity of human immunodeficiency virus (HIV)
Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
10. Neuropathy > grade 1 11. Receiving immunostimulatory agent 12. Prior allogeneic HSCT 13. Current seizure disorder requiring anti-epileptic therapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
- David Geffen School of Medicine at UCLA
accepting new patients
Los Angeles California 90095 United States - University of California San Francisco
accepting new patients
San Francisco California 94143 United States - Cedars-Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Genmab
- ID
- NCT04663347
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 396 study participants
- Last Updated