Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This is a single arm, dose escalation and expansion trial in which eligible patients will receive Epcoritamab every 28 days. The purpose of the escalation part of the trial is to determine the maximum tolerated dose and the recommended phase 2 dose (RP2D) as well as to establish the safety profile of epcoritamab GEN3013 (DuoBody®-CD3xCD20) in patients with relapsed, progressive or refractory B-Cell Lymphoma. In the expansion part, additional patients will be treated with epcoritamab to further explore and determine the safety and efficacy of epcoritamab.
Conditions
This trial is treating people with B-cell lymphoma
Eligibility
Inclusion
Main Inclusion Criteria - Escalation Part (recruitment completed)
Main Inclusion Criteria - Expansion & Optimization Parts
- Documented CD20 positive mature B cell neoplasm or CD20+ MCL
- DLBCL, de novo or transformed (including double hit or triple hit)
- PMBCL
- FL grade 3B
- Histologic confirmed FL
- MZL
- SLL
- MCL (prior BTKi or intolerant to BTKi)
- At least 2 therapies including an anti-CD20 monoclonal antibody containing chemotherapy combination regimen
- Either failed prior autologous hematopoietic stem cell transplantation or ineligible for autologous stem cell transplantation due to age or comorbidities
- At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes
Exclusion
Main Exclusion Criteria - All Parts
- Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening
- Known past or current malignancy other than inclusion diagnosis
- AST, and/or ALT >3 × upper limit of normal
- Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- Estimated CrCl <45 mL/min
- Known clinically significant cardiovascular disease
- Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor
- Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
- Seizure disorder requiring therapy (such as steroids or anti-epileptics)
- Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
- Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration
- Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue
- Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation
- Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in
- Known human immunodeficiency virus (HIV) infection
- Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
- Pregnancy or breast feeding
- Patient is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the patient
- Contraindication to all uric acid lowering agents
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Genmab
Scientific Title
A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
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