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

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Genmab

No Placebo Group

Trial Summary

What is the purpose of this trial?

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").

Research Team

Eligibility Criteria

Inclusion Criteria

Must sign an informed consent form prior to any screening procedures.

Has histologically or cytologically confirmed relapsed or refractory B-cell NHL. All subjects must have received at least 2 prior lines of systemic therapy, and, For FL and DLBCL, at least 1 of the 2 prior lines of treatment must have been a CD20 containing systemic regimen; For CLL, subjects must have received at least one prior line of BTK inhibitor or BCL 2 inhibitor.

Has one of the eligible subtypes of B-cell NHL: (DLBCL, HGBCL, PMBCL, FL, MCL, MZL, SLL, or CLL).

Exclusion Criteria

You have had or currently have a different type of cancer than the one being studied.

You have received chemotherapy or radiation therapy within the past two weeks before starting GEN3009.

You have a condition that affects your immune system and requires strong medications to control it.

Treatment Details

Interventions

• Epcoritamab (Monoclonal Antibodies)
• GEN3009 (Monoclonal Antibodies)

Participant Groups

Group I: Monotherapy Arm Experimental Treatment 1 Intervention

Group II: Combination Arm Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois