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Monoclonal Antibodies

GEN1047 for Cancer

Phase 1 & 2
Recruiting
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
Participants with ovarian cancer must have documented progressive disease on or after last prior treatment and within 60 days of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial studies the safety and effectiveness of an antibody, GEN1047, in treating cancer. Participants will get GEN1047 in two parts to assess safety, dose and preliminary activity.

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).Check my eligibility
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.See study design
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 ovarian cancer has worsened after my last treatment, within the past 60 days.
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I can provide all CT scans since my last treatment didn't work.
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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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I can provide a sample of my tumor before starting the trial.
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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 can provide a sample of my tumor before starting the trial.
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My cancer has returned or didn't respond to standard treatments, or I can't tolerate them.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can provide all CT scans since my last treatment didn't work.
Select...
My latest scan shows my cancer has progressed despite treatment, and was done within the last 28 days.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Escalation: Number of Participants with Dose Limiting Toxicities
Escalation: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Expansion: Objective Response Rate (ORR)
Secondary outcome measures
Escalation and Expansion: Area Under the Concentration-time Curve from Time 0 to Time of Last Dose (AUClast)
Escalation and Expansion: Clearance
Escalation and Expansion: Disease control rate (DCR)
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: GEN1047Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor
56 Previous Clinical Trials
11,732 Total Patients Enrolled

Media Library

GEN1047 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05180474 — Phase 1 & 2
Squamous Cell Carcinoma Research Study Groups: GEN1047
Squamous Cell Carcinoma Clinical Trial 2023: GEN1047 Highlights & Side Effects. Trial Name: NCT05180474 — Phase 1 & 2
GEN1047 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180474 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this particular trial actively seeking participants?

"According to clinicaltrials.gov, the search for participants is still ongoing - this trial was initially advertised on December 13th 2021 and has been regularly updated ever since its inception on April 19th 2023."

Answered by AI

What is the participant count of this experiment?

"Affirmative. Clinicaltrials.gov data confirms that this research project, which was originally posted on December 13th 2021 is actively recruiting participants. Five hundred patients need to be enrolled at 8 different medical centres."

Answered by AI

How many research sites are undertaking this trial?

"8 clinical sites, located in Nashville, Pamplona and Paris amongst other cities, are running this trial. When considering participation, it is best to select the nearest location so as to reduce travel time."

Answered by AI
~224 spots leftby Jan 2026