GEN1286 for Cancer

Recruiting at 2 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must not be taking: Topoisomerase 1-based ADCs

Disqualifiers: Advanced solid tumors, others

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

Compensation: Varies

Number of Visits: Unknown

260 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors. This trial consists of 2 parts: * Part A: Dose escalation and dose level expansion * Part B: Tumor-specific expansion with dose optimization

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of 2 weeks for chemotherapy or small molecule therapy and 4 weeks for antibody-based treatments before starting the study drug. If your disease has progressed on treatment, a 2-week washout period is needed. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Research Team

Study Official

Principal Investigator

Genmab

Eligibility Criteria

This trial is for adults with advanced solid tumors that have spread or can't be removed by surgery. Participants should have tried other treatments unless they couldn't, didn't want to, or the treatment wasn't available locally. They must be mostly healthy otherwise (with minor exceptions) and able to do daily activities without much help.

Inclusion Criteria

My cancer is confirmed to be an advanced solid tumor.

I am fully active or can carry out light work.

Measurable disease at baseline as defined per RECIST version 1.1

Exclusion Criteria

Other serious underlying medical condition that, in the opinion of the investigator, would impair the participant's ability to receive or tolerate the planned treatment and follow-up

I have waited the required time after my last cancer treatment before starting a new one.

Concurrent participation in another clinical trial of an investigational therapy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Expansion

Part A involves dose escalation and dose level expansion to evaluate safety and tolerability

21 days per cycle

Tumor-specific Expansion

Part B involves tumor-specific expansion with dose optimization to assess anti-tumor activity

Up to approximately 3 years 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GEN1286

Trial Overview GEN1286 is being tested for its safety and effectiveness against advanced solid tumors. The trial has two parts: Part A finds the right dose and expands it; Part B focuses on specific tumor types with optimized dosing.

Participant Groups

Group I: GEN1286 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