RecruitingPhase 1NCT07416123

A Study of GEN1106 in Participants With Solid Tumors

First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors


Sponsor

Genmab

Enrollment

103 participants

Start Date

Apr 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer. The trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial. For each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant). Participation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \[CT\] scans) to monitor whether the treatment is safe and effective. All participants will receive active drug; no one will be given placebo.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called GEN1106 for people with solid tumors and urothelial carcinoma. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGEN1106

Intravenous (IV) infusion.


Locations(10)

Yale Cancer Center

New Haven, Connecticut, United States

START New York Long Island LLC

Lake Success, New York, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

West Cancer Center and Research Institute

Germantown, Tennessee, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Hospital HM Nou Delfos

Barcelona, Spain

START Madrid - Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

START Madrid - Centro Integral Oncologico Clara Campal

Madrid, Spain

Hospital Universitario Quironsalud Madrid

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07416123


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