Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

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

Details

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

Keywords

Diffuse Large B-Cell Lymphoma Follicular Lymphoma Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Gemcitabine Cytarabine Dexamethasone Prednisone Cyclophosphamide Bendamustine Hydrochloride Rituximab Carboplatin 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

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genmab
ID
NCT04663347
Phase
Phase 1/2
Study Type
Interventional
Last Updated