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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
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 belowSelect...
I am a woman and at least 18 years old or the legal age of consent.
Select...
My cancer is advanced or has spread, and this was confirmed by a lab test.
Select...
I am at least 18 years old or the legal age of consent where the trial is.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My solid tumor cancer has no other standard treatments likely to help.
Select...
I have at least one tumor that can be measured and was not treated with radiation.
Select...
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:Select...
I have had a bowel blockage due to my illness.
Select...
I have new or worsening brain tumors or spinal cord compression.
Select...
I have previously been treated with therapies targeting CD3/B7H4 or received cell-based treatments.
Select...
I have not had major heart problems in the last 6 months.
Select...
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
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: GEN1047Experimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
GenmabLead Sponsor
68 Previous Clinical Trials
13,800 Total Patients Enrolled
Study OfficialStudy DirectorGenmab
16 Previous Clinical Trials
5,081 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a bowel blockage due to my illness.I am a woman and at least 18 years old or the legal age of consent.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.I am fully active or restricted in physically strenuous activity but can do light work.I have new or worsening brain tumors or spinal cord compression.My solid tumor cancer has no other standard treatments likely to help.I have at least one tumor that can be measured and was not treated with radiation.I have previously been treated with therapies targeting CD3/B7H4 or received cell-based treatments.I can provide a sample of my tumor before starting the trial.My cancer has returned or didn't respond to standard treatments, or I can't tolerate them.My ovarian cancer has worsened after my last treatment, within the past 60 days.I am fully active or restricted in physically strenuous activity but can do light work.I have not had major heart problems in the last 6 months.I have or had lung inflammation not caused by an infection that needed steroids.My latest scan shows my cancer has progressed despite treatment, and was done within the last 28 days.You must have at least one spot that can be measured by your doctor.
Research Study Groups:
This trial has the following groups:- Group 1: GEN1047
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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