GEN1047 for Cancer

Not currently recruiting at 37 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests GEN1047, an experimental treatment for solid tumors such as breast, endometrial, ovarian, and certain lung cancers. Researchers aim to understand how GEN1047 affects the body, how the body processes it, and its effectiveness against these cancers. The trial seeks to identify potential side effects while monitoring the drug's efficacy. Ideal candidates for this trial include individuals with these cancers who have not succeeded with standard treatments or cannot use them. Participants will receive active treatment and remain in the study for about 8 months. As a Phase 1 trial, this research focuses on understanding how GEN1047 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that GEN1047 is likely to be safe for humans?

Research shows that GEN1047 remains in the early stages of human safety testing. Most information comes from animal studies or lab tests, and detailed human safety data is not yet available. Scientists continue to study how well people tolerate GEN1047 and what side effects it might cause.

Since this trial is in the early phases, GEN1047 has not been tested in many people. This phase focuses on identifying side effects and understanding the body's reaction to the drug. It aims to identify any risks before GEN1047 might be used more widely. While there is hope for its benefits, researchers are closely monitoring the safety of GEN1047 in humans. Participants in this trial contribute to gathering the first data on GEN1047's safety for people with solid tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for cancer, like chemotherapy and radiation, work by attacking rapidly dividing cells, which can often affect healthy cells too. But GEN1047 works differently, targeting specific proteins on cancer cells to stop their growth while sparing healthy cells. This targeted approach may lead to fewer side effects and improved effectiveness. Researchers are excited about GEN1047 because it represents a more precise way to treat cancer, potentially leading to better outcomes for patients.

What evidence suggests that GEN1047 might be an effective treatment for cancer?

Research has shown that GEN1047, a bispecific antibody, can attach to two targets simultaneously. It is designed to help the immune system attack cancer cells, particularly those with B7H4-positive tumors, which are often difficult to treat. Previous studies have demonstrated that these antibodies can effectively fight tumors by boosting the body's natural immune response. Early results suggest that GEN1047 may benefit patients with advanced solid tumors. The ongoing trial focuses on understanding its effectiveness and potential side effects. ^{1 4 6 7 8}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

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 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.

I am at least 18 years old or the legal age of consent where the trial is.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05180474

Study Details | NCT05180474 | GEN1047 for Solid Tumors The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: The side effects seen with GEN1047 ...

2. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/56075/pdf

escalation trial with expansion cohorts to evaluate safety of ... Crosslinking of CD3* and B7H4 by GEN1047 may have therapeutic benefits in patients with selected solid tumors in advanced stages who have very ...

3. clinicaltrials.eu clinicaltrials.eu/inn/gen1047/

GEN1047: A New Investigational Treatment for Solid Tumors A groundbreaking clinical trial is underway to evaluate the safety and effectiveness of GEN1047, a new drug designed to target malignant solid tumors. This ...

4. tipranks.com tipranks.com/news/company-announcements/genmabs-gen1047-trial-a-promising-step-in-cancer-treatment-2

Genmab's GEN1047 Trial: A Promising Step in Cancer ... The intervention being tested is GEN1047, a bispecific antibody designed to induce T-cell mediated cytotoxicity against B7H4-positive tumor ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12032835/

Application and future prospects of bispecific antibodies in ... Bispecific antibodies (bsAbs) bind two different antigens or epitopes simultaneously and have been shown to enhance antitumor efficacy with suitable safety ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=GCT1047-01

GEN1047 for Solid Tumors - First in Human (FIH) Trial The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: * The side effects seen with GEN1047 * What the ...

7. clinicaltrials.eu clinicaltrials.eu/trial/56499/

Study of GEN1047 for Safety in Patients with Malignant ... This study investigates the safety and dosage of GEN1047, a new drug being tested for the treatment of various types of malignant solid ...

8. trial.medpath.com trial.medpath.com/clinical-trial/f1c764f64677e24b/euctr2021-001790-23-dk-gen1047-solid-tumors-safety-trial

A Safety study of GEN1047 in patients with malignant solid ... ... GEN1047 may be beneficial (breast cancer, endometrial cancer, ovarian cancer, squamous non-small-cell lung cancer [NSCLC-SCC]). • Subjects with ovarian cancer ...