RecruitingPhase 1NCT07695831

A Phase 1 Trial of GEN1119 in Participants With Solid Tumors

First-In-Human, Open-Label Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GEN1119 in Participants With Solid Tumors


Sponsor

Genmab

Enrollment

112 participants

Start Date

Aug 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this trial is to learn about the safety and efficacy of GEN1119 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 will test different doses of GEN1119 to find out if it is safe and to determine what are the best doses to use. The second part will further refine this optimal dose. The third part continues to test the safety and how well GEN1119 works in additional participants with specific cancer types and at doses chosen based on the results of the first 2 parts of the trial. For each participant, the trial will last approximately 18 months but this may vary for each individual. This includes a Screening Period of up to 21 days before receiving trial treatment, an estimated 5 months of treatment (the duration of treatment may vary for each participant), and approximately 12.5 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 drug called GEN1119 for people with solid tumours. The study is currently recruiting participants at 4 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

DRUGGEN1119

Administered at certain DLs on specified days.


Locations(6)

Centre Eugene Marquis

Rennes, Ille Et Vilaine, France

Kansai Medical University Hospital

Hirakata, Osaka, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR

Koto-Ku, Tokyo, Japan

START - Hospital HM Nou Delfos

Barcelona, Catalonia, Spain

START Madrid - Hospital Universitario Fundacion Jimenez Díaz

Madrid, Spain

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NCT07695831


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