NCT04663347 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

One/TwoPhase One/Two

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Treatment | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Follicular Lymphoma

Trial Overview Read MoreRead more

This phase I/II trial is trying to understand how safe and tolerable a targeted therapy drug (epcoritamab) is when combined with standard of care treatments, including chemotherapy, steroids and other targeted therapy drugs, in people with B-cell Non-Hodgkin Lymphoma.
 

This trial is treating patients with B-cell non-Hodgkin lymphoma and Follicular lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific 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

Commercial Sponsor

Genmab

Summary

This is a non-randomised trial with five experimental arms. Each arm has 2 parts: Part 1 (dose escalation) and Part 2 (expansion). Within each arm, participants can only participate in one part. Experimental Arm 1 is investigating epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Experimental Arm 2 is investigating epcoritamab + rituximab and lenalidomide (R2) in people with relapsed/refractory (R/R) follicular lymphoma (FL). Experimental Arm 3 is investigating epcoritamab + rituximab and bendamustine (BR) in people with previously untreated FL. Experimental Arm 4 is investigating epcoritamab + rituximab, cisplatin, cytarabine, and dexamethasone (R-DHAX/C) in people with R/R DLBCL eligible for autologous stem cell transplant (ASCT). Experimental Arm 5 is investigating epcoritamab + gemcitabine and oxaliplatin (GemOx) in people with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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