GEN1119 in people with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of GEN1119 in participants with various solid tumors. The trial is conducted in sequential parts to identify the safest and most effective dose, followed by dose refinement and expansion into additional cancer types. Each participant undergoes screening, about five months of treatment, and roughly 12.5 months of follow-up, totaling up to 18 months. The study is sponsored by Genmab and is conducted at sites in France, Japan, and is coordinated across multiple centers.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours.
* Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1119 may be a suitable option in the opinion of the investigator.
* Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Have acceptable laboratory test results before GEN1119 administration per protocol

Key Exclusion Criteria:

* Prior treatment with certain protocol-defined therapy.
* Prior treatment with T-cell engagers, chimeric antigen receptor T-cell (CAR-T-cell) therapies, other protocol defined therapies, or other therapeutic moieties targeting certain protocol-defined molecules.
* Treatment with an anticancer agent within 4 weeks or within 5 half lives of the drug, whichever is shorter, but not within 2 weeks before Cycle 1 Day 1 (C1D1).
* Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or lower, except for anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ Grade 2. There is no limitation for alopecia from previous therapies.
* Participant should not have active Hepatitis B infection. Participants with prior infections or chronic infections are allowed if monitored or treated as per local SOC and are negative for hepatitis B virus (HBV) DNA measured viral load.
* Hepatitis C virus (HCV): Known active HCV infection (defined as positive for HCV ribonucleic acid \[RNA\] \[qualitative\]).

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Where it's running

• Centre Eugene Marquis
  Rennes, Ille Et Vilaine, France Recruiting
• Kansai Medical University Hospital
  Hirakata, Osaka, Japan Recruiting
• National Cancer Center Hospital
  Chuo Ku, Tokyo, Japan Recruiting
• The Cancer Institute Hospital Of JFCR
  Koto-Ku, Tokyo, Japan Recruiting
• START - Hospital HM Nou Delfos
  Barcelona, Catalonia, Spain Recruiting
• START Rioja - Hospital Universitario San Pedro
  Logroño, La Rioja, Spain Recruiting

Study contacts

• Study coordinator: Genmab Trial Information
• Email: clinicaltrials@genmab.com
• Phone: +4570202728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.