Purpose

A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, PK, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents in subjects with B-NHL.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject must sign an ICF 2. At least 18 years of age 3. 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 CT or MRI 4. ECOG PS score of 0, 1 or 2 5. Acceptable organ function at screening 6. CD20-positive NHL at most recent representative tumor biopsy 7. If of childbearing potential subject must practicing a highly effective method of birth control 8. 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 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 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.

Exclusion Criteria

  1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab 2. Any prior treatment with a bispecific antibody targeting CD3 and CD20. 3. Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab 4. Clinically significant cardiovascular disease 5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results 6. 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 7. Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection 8. Known history of seropositivity of human immunodeficiency virus (HIV) 9. Suspected active or latent tuberculosis 10. Neuropathy > grade 1 11. Receiving immunostimulatory agent 12. Prior allogeneic HSCT

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 - Epcoritamab + R-CHOP
Epcoritamab + R-CHOP in subjects with previously untreated DLBCL
  • Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
    21-day cycles
    Other names:
    • R-CHOP
  • Biological: Epcoritamab
    Epcoritamab will be administered in combination with the respective standard of care chemotherapy.
    Other names:
    • GEN3013; DuoBody®-CD3xCD20
Experimental
Arm 2 - Epcoritamab + R- Lenalidomide
Epcoritamab + R- Lenalidomide in subjects with R/R FL
  • Drug: rituximab and lenalidomide
    28-day cycles
    Other names:
    • R2
  • Biological: Epcoritamab
    Epcoritamab will be administered in combination with the respective standard of care chemotherapy.
    Other names:
    • GEN3013; DuoBody®-CD3xCD20
Experimental
Arm 3 - Epcoritamab + BR
Epcoritamab + BR in subjects with previously untreated FL
  • Drug: rituximab and bendamustine
    28-day cycles
    Other names:
    • BR
  • Biological: Epcoritamab
    Epcoritamab will be administered in combination with the respective standard of care chemotherapy.
    Other names:
    • GEN3013; DuoBody®-CD3xCD20
Experimental
Arm 4 - Epcoritamab + R-DHAX/C
Epcoritamab + R-DHAX/C in subjects with R/R DLBCL Eligible ASCT
  • Drug: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
    21-day cycles
    Other names:
    • R-DHAX/C
  • Biological: Epcoritamab
    Epcoritamab will be administered in combination with the respective standard of care chemotherapy.
    Other names:
    • GEN3013; DuoBody®-CD3xCD20
Experimental
Arm 5 - Epcoritamab + GemOx
Epcoritamab + GemOx in subjects with R/R DLBCL Ineligible ASCT
  • Drug: gemcitabine and oxaliplatin
    28-day cycles
    Other names:
    • GemOx
  • Biological: Epcoritamab
    Epcoritamab will be administered in combination with the respective standard of care chemotherapy.
    Other names:
    • GEN3013; DuoBody®-CD3xCD20
Experimental
Arm 6 - Epcoritamab + R- Lenalidomide
Epcoritamab + R- Lenalidomide in subjects with previously untreated FL
  • Drug: rituximab and lenalidomide
    28-day cycles
    Other names:
    • R2
  • Biological: Epcoritamab
    Epcoritamab will be administered in combination with the respective standard of care chemotherapy.
    Other names:
    • GEN3013; DuoBody®-CD3xCD20
Experimental
Arm 7 - Epcoritamab maintenance
Epcoritamab alone in subjects with FL who achieved a CR or PR after receiving SOC treatment
  • Biological: Epcoritamab Maintenance
    Epcoritamab will be administered alone as maintenance therapy.
    Other names:
    • GEN3013; DuoBody®-CD3xCD20

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Genmab

Study Contact

Genmab A/S Trial Information
+45 70202728
clinicaltrials@genmab.com

Detailed Description

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 + rituximab and lenalidomide (R2) in subjects with previously untreated FL - Arm 7: epcoritamab maintenance in subjects with FL who achieve CR or PR with SOC treatment

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.