What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) using monoclonal antibodies and targeted therapies, such as cetuximab and pembrolizumab, often result in side effects like skin reactions (rash), gastrointestinal issues (diarrhea), and infusion-related reactions. Other notable side effects include fatigue, neutropenia, and mucositis. Severe side effects can include ulcerative keratitis, peripheral neuropathies, and venous thromboembolism.

What prior FDA approvals exist?

For the treatment of squamous cell carcinoma, the FDA has approved several monoclonal antibodies that target specific cancer cells. Cetuximab, an EGFR inhibitor, is one such drug that has been used in combination with chemotherapy for SCC. Pembrolizumab, an anti-PD-1 antibody, has also been approved for SCC, particularly in cases where the cancer expresses PD-L1. These treatments work by targeting specific pathways involved in tumor growth and immune evasion, similar to the investigational drug GEN1047, which is being studied for its ability to inhibit tumor growth by targeting specific cancer cells.

What other types of research exist?

Promising alternatives to GEN1047 for Squamous Cell Carcinoma patients include: 1) MAb MINT5, which blocks human EGF-R function with low immunogenicity, making it suitable for carcinoma immunotherapy. 2) Anti-PD-L1 mAb, which has shown significant efficacy in delaying tumor outgrowth in immunogenic tumor models. 3) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which is used in various carcinomas and may be effective in SCC with high PD-L1 expression.

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Monoclonal Antibodies

GEN1047 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be a female and at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of consent

Participant must have advanced or metastatic, histologically confirmed diagnosis

Must not have

Participant has a history of bowel obstruction related to underlying disease

Participant with new or progressive brain metastases or spinal cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

Since GEN1047 is new to humans, exact side effects are unknown but may include immune system reactions such as inflammation in organs or tissues, fatigue due to immune activation, infusion-related reactions from receiving antibodies intravenously, and potential risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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My solid tumor cancer has no other standard treatments likely to help.

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I have at least one tumor that can be measured and was not treated with radiation.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bowel blockage due to my illness.

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

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

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I have not had major heart problems in the last 6 months.

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I have or had lung inflammation not caused by an infection that needed steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Escalation: Number of Participants with Dose Limiting Toxicities (DLT)

Escalation: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Expansion: Objective Response Rate (ORR)

Secondary study objectives

Escalation and Expansion: Disease control rate (DCR)

Escalation and Expansion: Duration of Response (DOR)

Escalation and Expansion: Time to response (TTR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GEN1047Experimental Treatment1 Intervention

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Squamous Cell Carcinoma (SCC) include surgery, radiation therapy, and chemotherapy. Targeted therapies, such as monoclonal antibodies, are also used. These antibodies, like GEN1047, work by specifically targeting and binding to proteins on the surface of cancer cells, inhibiting their growth and survival. This targeted approach is crucial for SCC patients as it can potentially reduce side effects and improve treatment efficacy by sparing normal cells and focusing on cancerous cells.