GEN3017 for Lymphoma

Recruiting at 8 trial locations

Overseen By Genmab Trial Information

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: CNS tumor, Recent chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

9 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing GEN3017, a new injectable drug, in patients whose specific types of cancer have not responded to other treatments. The drug works by targeting and attacking cancer cells with a unique marker.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop all current medications, but you cannot have had chemotherapy within 2 weeks, major surgery within 4 weeks, or be on certain immunosuppressive drugs or high-dose corticosteroids within 14 days before starting the trial.

Research Team

Study Official

Principal Investigator

Genmab

Eligibility Criteria

This trial is for adults with relapsed or refractory CD30-expressing Hodgkin and Non-Hodgkin Lymphomas, who have at least one measurable lesion. Participants should be in good physical condition (ECOG score 0-1) and not have received certain recent treatments like chemotherapy, major surgery, or investigational drugs.

Inclusion Criteria

I am at least 18 years old, or 16 if I am in the US or Australia with cHL.

My cancer is a relapsed or refractory classical Hodgkin lymphoma or T-cell lymphoma.

My tumor biopsy shows CD30-positivity.

Exclusion Criteria

I haven't had chemotherapy in the last 2 weeks or major surgery in the last 4 weeks.

I haven't had curative radiotherapy in the last 4 weeks or palliative radiotherapy in the last 2 weeks.

I have not received any live vaccines in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Evaluation of dose-limiting toxicities to determine the recommended phase 2 dose and maximum tolerated dose for relapsed or refractory CD30+ lymphomas

21 days per cycle

Multiple visits per cycle

Expansion

Assessment of anti-tumor activity, safety, immunogenicity, pharmacokinetics, and pharmacodynamics at the recommended phase 2 dose

Up to 5 years

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• GEN3017

Trial Overview The trial tests GEN3017 as a solo treatment to see how safe it is and how well it works against lymphoma. It's given through under-the-skin injections. Everyone in the study will receive this active drug; there's no placebo group.

Participant Groups

Group I: R/R CD30+ cHL Cohort Experimental Treatment 1 Intervention

Group II: R/R CD30+ TCL Cohort Experimental Treatment 1 Intervention

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