Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Diffuse Large B-Cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

GEN3009 will be administered by intravenous (IV) infusion in cycles of 28 days

GEN3009

Epcoritamab will be administered by subcutaneous (SC) injections in cycles of 28 days

Epcoritamab

The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009. GEN3009 will be studied in a broad group of cancer patients, having different kinds of lymphomas. All patients will get GEN3009 either as a single treatment (monotherapy) or in combination with another antibody-candidate for treatment of cancer in the blood. The study consists of two parts: Part 1 tests increasing doses of GEN3009 ("escalation"), followed by Part 2 which tests the recommended GEN3009 dose from Part 1 ("expansion").

This trial will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). All subjects in Part 1 will receive GEN3009, administered at various dose levels in 28-day cycles. Dose Limiting Toxicity (DLT) will be assessed during the first treatment cycle of Part 1 and the Maximum Tolerated Dose (MTD) and/or Recommended phase 2 dose (RP2D) will be identified.

Subjects in Part 2 will be treated with the Part 1-defined RP2D of GEN3009. Some subjects will receive GEN3009 in combination of a fixed dose of another antibody-candidate. Subjects in Part 2 are assigned either to one of 3 groups: Part 2 Monotherapy (hereafter referred to as 'Part 2A'), Part 2 Combination Safety Run-in ('Part2B') or Part 2 Combination ('Part2C').

Various types of B-cell NHLs are studied, including diffuse large B cell lymphoma (DLBCL), high-grade B cell lymphoma (HGBCL), mantle cell lymphoma (MCL), primary mediastinal large B-cell lymphoma (PMBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas

Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts

To identify the recommended phase 2 dose (RP2D) and if reached, the MTD

To assess the safety and tolerability of GEN3009 as monotherapy and of GEN3009 in combination

Clinical laboratory parameters assessed: hematology, chemistry, coagulation, immunoglobulins and urinalyses

Vital signs assessed: systolic and diastolic blood pressure, heart rate, temperature and pulse oximetry

Assessment of frequency of dose interruptions, dose delays and dose intensity

To evaluate preliminary anti-tumor efficacy of GEN3009 as monotherapy by change in tumor size

To evaluate preliminary anti-tumor efficacy of GEN3009 in combination by change in tumor size

To evaluate preliminary anti-tumor efficacy of GEN3009 as monotherapy and in combination by change in tumor size

Clinical Lab parameters assessed: hematology, chemistry, coagulation, immunoglobulins and urinalyses

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas	NCT04358458	Diffuse Large B... Follicular Lymp... Marginal Zone L... Small Lymphocyt... Mantle Cell Lym... Chronic Lymphoc... High-grade B-ce... Primary Mediast...	GEN3009 Epcoritamab	18 Years -	Genmab
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas	NCT04358458	Diffuse Large B... Follicular Lymp... Marginal Zone L... Small Lymphocyt... Mantle Cell Lym... Chronic Lymphoc... High-grade B-ce... Primary Mediast...	GEN3009 Epcoritamab	18 Years -	Genmab

Spots Global Cancer Trial Database for gen3009

Every month we try and update this database with for gen3009 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gen3009

Every month we try and update this database with for gen3009 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gen3009 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.