GEN1057 for Cancer

Recruiting at 4 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Genmab

Must not be taking: Investigational drugs, Live vaccines

Disqualifiers: Symptomatic brain metastases, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 months

45 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to study the antibody GEN1057 when used as a single agent for the treatment of certain types of cancer. Trial details include: * The trial duration will be up to approximately 11 months. * The treatment duration will be up to approximately 4 months (the duration of treatment may vary for each participant) and the follow-up duration will be approximately 6 months. Participation in the trial will require visits to the site. All participants will receive active drug; no one will be given placebo.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had certain investigational treatments or live vaccines within 28 days before starting the trial.

Research Team

Study Official

Principal Investigator

Genmab

Eligibility Criteria

This trial is for adults with advanced solid tumors that have worsened after standard treatments, or when no other standard treatment can help. It's also for those who choose not to undergo available therapies but might benefit from the experimental drug GEN1057, as judged by a doctor.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Have measurable disease according to RECIST v1.1

Have a life expectancy of ≥3 months

Exclusion Criteria

I have or had cancer types other than the one I am seeking treatment for.

I haven't had any experimental cancer treatments, live vaccines, or used investigational medical devices in the last 28 days.

Side effects from my past cancer treatments have mostly gone away, except for possible mild issues with appetite, thyroid, nerve pain, hair loss, or hearing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive GEN1057 as monotherapy for dose escalation to evaluate safety, tolerability, and early efficacy signals

4 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Periodic visits (in-person)

Treatment Details

Interventions

• GEN1057

Trial Overview The study focuses on the safety and cancer-fighting effects of GEN1057 as a single agent. Participants will be treated for up to 4 months and followed up for about 6 months, receiving active medication throughout without any placebos involved.

Participant Groups

Group I: GEN1057 Monotherapy 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