Trial details
A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma (Genmab 01)
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: Genmab 01
Official title: A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma (Genmab 01)
Principal Investigator: Dr. Neil Berinstein
Cancer type: Blood Related
Cancer location: Blood Related
Disease stage: Early Cancer
Trial phase: Phase 1, Phase 2
Intervention: Biological: Epcoritamab
Registration #:
NCT03625037 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase-2 dose (RP2D), as well as to establish the safety profile of epcoritamab in patients with relapsed, progressive or refractory B-Cell Lymphoma In the expansion part, additional patients will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.
Main Inclusion Criteria Escalation Part -Documented CD20+ mature B-cell neoplasm -Diffuse large B-cell lymphoma - de novo or transformed -High-grade B-cell lymphoma -Primary mediastinal large B-cell lymphoma -Follicular lymphoma -Mantle cell lymphoma -Small lymphocytic lymphoma -Marginal zone lymphoma (nodal, extranodal or mucosa associated) -Relapsed, progressive and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue. -ECOG performance status 0,1 or 2 -Patients must have measurable disease by CT, MRI or PET-CT scan -Acceptable renal function -Acceptable liver function Main Inclusion Criteria Expansion Part -Documented CD20 positive mature B cell neoplasm or CD20+ MCL -Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple hit) -Primary mediastinal large B cell lymphoma -Follicular lymphoma grade 3B -Histologic confirmed follicular lymphoma -Marginal zone lymphomas -Small lymphocytic lymphoma -Mantle Cell Lymphoma (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 NOTE: Other protocol defined Inclusion criteria may apply.
