GEN3014 for Blood Cancers

Recruiting at 62 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must not be taking: CD38 therapies, Investigational drugs

Disqualifiers: Cardiac disease, CNS tumor, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

252 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing GEN3014, an antibody medicine, in patients with blood cancers that have come back or didn't respond to previous treatments. GEN3014 helps the immune system find and destroy cancer cells. The study aims to find a safe dose and see how well it works. GEN3014 is part of a new wave of antibody-based therapies designed to enhance the immune system's ability to target and destroy cancer cells.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain treatments like chemotherapy or investigational drugs shortly before starting the trial, and some medications like corticosteroids have specific limits. It's best to discuss your current medications with the trial team.

Research Team

Study Official

Principal Investigator

Genmab

Eligibility Criteria

This trial is for adults with certain blood cancers like multiple myeloma or acute myeloid leukemia that have come back or didn't respond to treatment. They should be in a stable condition, not pregnant, and willing to use birth control. People can't join if they've had recent cancer treatments, stem cell transplants, active infections like hepatitis B/C or HIV, central nervous system involvement by the cancer, or are taking other experimental drugs.

Inclusion Criteria

Women who could become pregnant must have a negative pregnancy test before starting the study treatment. If you are in the Expansion Part B, you need to have a negative pregnancy test within 72 hours before starting the treatment.

I have never received anti-CD38 monoclonal antibodies for my relapsed or refractory multiple myeloma, and I live outside the US.

A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC

Exclusion Criteria

Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B)

I have a serious heart condition.

I have an ongoing or past hepatitis C infection that hasn't been cured.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of GEN3014 to identify a safe dose level

28 days per cycle

Multiple visits per cycle

Expansion Part A

Further evaluation of GEN3014 at the recommended dose in multiple cohorts

Up to 8 years

Expansion Part B

Comparison of GEN3014 IV with daratumumab SC in anti-CD38 mAb-naïve RRMM participants

Up to 8 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 8 years

Treatment Details

Interventions

• GEN3014

Trial Overview The trial tests GEN3014 (an antibody) for safety and effectiveness in relapsed/refractory blood cancers. It has three parts: finding a safe dose level (Dose Escalation), testing this dose further (Expansion Part A), and comparing GEN3014 with daratumumab (Expansion Part B). Participants will receive either GEN3014 or daratumumab but no placebos.

Participant Groups

Group I: GEN3014 Experimental Treatment 1 Intervention

Experimental: GEN3014 Participants in Dose Escalation phase with * RRMM * R/R AML Participants in Expansion Part A with * RRMM (anti-CD38 mAb-naïve) * RRMM (anti-CD38 mAb-refractory) * R/R DLBCL * R/R AML Participants in Expansion Part B with • RRMM (anti-CD38 mAb-naïve)

Group II: Daratumumab Active Control 1 Intervention

Participants in Expansion Part B with - RRMM (anti-CD38 mAb-naïve)

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