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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new antibody treatment, GEN1057, for individuals with advanced or spreading cancer who have not responded to standard treatments. The researchers aim to evaluate how GEN1057 works independently to combat cancer. Participants will receive the actual drug, not a placebo, over approximately 4 months, with follow-ups for about 6 months after treatment. Suitable candidates have a type of cancer that has worsened despite treatment and lack other viable treatment options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that GEN1057 is likely to be safe for humans?

Research shows that GEN1057 is being tested for certain types of cancer. Earlier studies found that some patients experienced side effects related to the treatment, but these were usually mild to moderate.

GEN1057 is in an early testing phase, so researchers are closely monitoring safety. This phase aims to determine the treatment's safety and potential side effects. While it doesn't provide complete safety information, it is a crucial step to ensure the treatment is well-tolerated.

Prospective trial participants might be among the first to try this treatment. Researchers will closely monitor participants' health to observe how their bodies respond to the drug. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard cancer treatments like chemotherapy and radiation, which often impact both healthy and cancerous cells, GEN1057 is unique because it specifically targets cancer cells, potentially reducing side effects. Researchers are excited about GEN1057's new mechanism of action—it works by engaging and enhancing the body's immune response directly against cancer cells. This targeted approach could offer a more effective treatment option with fewer adverse effects, making it a promising candidate in the fight against cancer.

What evidence suggests that GEN1057 might be an effective treatment for cancer?

Research has shown that GEN1057, a special type of antibody, can fight cancer by targeting specific proteins on cancer cells. In lab tests, certain doses of GEN1057 significantly shrank tumors and extended the lifespan of animals. This treatment induces cancer cells to self-destruct while sparing healthy cells. By binding to unique markers on tumors, GEN1057 aims to precisely attack cancer cells. Although human studies provide limited information, early results from animal research are promising for its effectiveness against certain cancers. ^{4 6 7 8 9}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. bioworld.com bioworld.com/articles/719866-bispecific-antibody-gen-1057-induces-apoptosis-through-dr4-and-fap-dual-engagement

Bispecific antibody GEN-1057 induces apoptosis through ... In the gastric PDX model CTG-1234, treatment with GEN-1057 at 0.5 and 2 mg/kg led to significant tumor regression and prolongation of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06573294

Study Details | NCT06573294 | Trial to Assess the Safety ... 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:.

3. ir.genmab.com ir.genmab.com/static-files/e17c16da-89cb-4e68-a34e-9222da5e4098

Genmab Interim Report GEN1057 is designed for the conditional DR4 transactivation- mediated tumor cell killing by crosslinking FAPα expression on cancer-associated ...

4. tipranks.com tipranks.com/news/company-announcements/genmabs-gen1057-trial-a-new-hope-for-cancer-treatment

Genmab's GEN1057 Trial: A New Hope for Cancer ... The study aims to assess the safety and antitumor activity of the antibody GEN1057 in treating certain types of cancer.

5. ir.genmab.com ir.genmab.com/static-files/8812d624-2941-435c-8bb6-7a3749a4c213

Genmab Interim Report Q2 2025 GEN1057 is designed for the conditional DR4 transactivation- mediated tumor cell killing by crosslinking FAPα expression on cancer-associated ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=GCT1057-01

Trial to Assess the Safety and Antitumor Activity of ... 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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06573294

Study Details | NCT06573294 | Trial to Assess the Safety ... 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.

8. clin.larvol.com clin.larvol.com/trial-detail/NCT06573294

Trial to Assess the Safety and Antitumor Activity of ... Number of Participants With Treatment-emergent Adverse Events (AEs), From first dose until the end of the safety follow-up period (approximately 5 months).

9. tipranks.com tipranks.com/news/company-announcements/genmabs-gen1057-trial-a-new-hope-in-cancer-treatment

Genmab's GEN1057 Trial: A New Hope in Cancer ... ' The study aims to assess the safety and antitumor activity of the antibody GEN1057 in treating advanced and metastatic malignant solid tumors.