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Study Summary
This trial will test how safe and effective GEN1042 is in treating patients with metastatic or locally advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I still have side effects from past cancer treatments.I am 18 years old or older.My melanoma, NSCLC, or CRC has returned or didn’t respond to treatment, and there’s no standard treatment left.I am part of the dose expansion phase of a combination therapy trial.My lung cancer is advanced, and I haven't had any cancer treatments yet.My cancer has spread, cannot be surgically removed, and there's no standard treatment for it.I am part of the dose expansion phase of a combination therapy trial.I am receiving treatment alone, not combined with other treatments.I haven't taken cancer drugs within the last 21 days or 5 half-lives before starting GEN1042.Applies to everyone participating in the study, regardless of the phase.I haven't had chemotherapy, biological therapy, or major surgery within the last 3 weeks or 5 half-lives of the drug before starting the trial.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My cancer has spread, cannot be surgically removed, and there's no standard treatment for it.I have advanced melanoma that cannot be surgically removed and haven't received systemic treatment for it.I am fully active or can carry out light work.I have metastatic pancreatic cancer and haven't received any treatment for it.You have a medical condition where your own immune system attacks your body.I am participating in a trial phase involving increasing doses of a single drug.This applies to all participants, regardless of the phase of the clinical trial.My liver, kidneys, heart, and bone marrow are functioning well.My head/neck cancer has returned or spread, hasn't been treated yet, and shows PD-L1.I have or had lung inflammation treated with steroids.I haven't had any radiotherapy in the last 14 days or lung radiation over 30 Gy in the last 6 months.My melanoma, NSCLC, or CRC has returned or didn’t respond to treatment and there’s no standard therapy left for me.You have had severe allergic reactions (grade 3 or higher) to antibody-based treatments in the past.I have not had radiotherapy in the last 14 days.
- Group 1: Combination Therapy - Dose Expansion Part
- Group 2: Monotherapy - Dose Escalation and Dose Expansion parts
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is participation in this trial available at present?
"Affirmative. Documents found on clinicaltrials.gov attest to the fact that this medical trial is currently searching for participants, having been first posted in September 2019 and last updated August 2021. 447 volunteers are needed from 4 different sites for enrollment."
What has been the previous research involving GEN1042?
"In 1997, GEN1042 was initially explored at City of Hope Comprehensive Cancer Center. Since then, an impressive number of 3003 trials have been completed and 2439 live studies are currently being conducted across the US with many running out of Charlotte, North carolina."
How many sites are actively monitoring this clinical experiment?
"This clinical trial is now running in 4 distinct locations, including Charlotte, Nashville and Philadelphia. For those interested in the study it is vital to select a site closest to you so as not to incur excessive travel costs."
What is the ambition of this research project?
"This experiment, monitored until the conclusion of its safety follow-up period (2 months after last dose), seeks to uncover the Maximum Tolerated Dose (MTD) for GEN1042 administered alone or as part of a combined treatment. The Secondary outcomes include; Adverse Events and Serious Adverse Events percentages, Area Under the Concentration Time Curve (AUC) & Maximum Concentration (Cmax) Pharmacokinetic parameters, and anti-drug antibody incidences."
What conditions does GEN1042 generally address?
"GEN1042 is a popular treatment for many afflictions, notably hodgkin disease, those who have had exposure to anthracycline-containing therapy in the past and patients with metastatic cutaneous squamous cell carcinoma."
How many individuals have enrolled in this medical experiment?
"Affirmative. Clinicaltrials.gov supplies evidence that this research endeavor is presently enrolling participants, which was first advertised on September 17th 2019 and edited most recently on August 22nd 2022. A total of 447 volunteers are needed to participate from four distinct sites."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
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