GEN1047 for Cancer

Recruiting at 36 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must not be taking: Steroids

Disqualifiers: Cardiovascular impairment, Brain metastases, Pneumonitis, others

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

Compensation: Varies

Number of Visits: 1

179 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests GEN1047, a new medicine that helps the immune system fight cancer, in patients with different types of solid tumors. The study aims to find a safe dose and see if it works well.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research Team

Study Official

Principal Investigator

Genmab

Eligibility Criteria

This trial is for women with certain advanced solid tumors like endometrial, breast, ovarian cancer or squamous cell carcinoma. They must have tried all standard treatments without success and be at least 18 years old. Participants need to provide a recent tumor tissue sample and CT scans, have measurable disease, and be in good physical condition (ECOGPS score of 0-1).

Inclusion Criteria

I am a woman and at least 18 years old or the legal age of consent.

I can provide all CT scans since my last treatment didn't work.

My cancer is advanced or has spread, and this was confirmed by a lab test.

Exclusion Criteria

I have had a bowel blockage due to my illness.

I have new or worsening brain tumors or spinal cord compression.

I have previously been treated with therapies targeting CD3/B7H4 or received cell-based treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Dose Escalation

Participants receive escalating doses of GEN1047 to determine safety and optimal dosing

3 months

Multiple visits (in-person)

Expansion

Participants receive up to two doses of GEN1047 to further evaluate safety and efficacy

3 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Periodic visits (in-person)

Treatment Details

Interventions

• GEN1047

Trial Overview GEN1047 is being tested; it's a new antibody that activates T-cells to kill B7H4-positive cancer cells. The study has two parts: the first finds the safest dose by gradually increasing it ('escalation'), then the second part tests this dose on more people ('expansion'). Everyone in the trial will receive GEN1047.

Participant Groups

Group I: GEN1047 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