GEN1106 for solid tumors, including metastatic urothelial (bladder) cancer.

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 Phase 1 trial uses a dose-escalation and expansion design to find safe doses and to study safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of GEN1106. Part 1 will identify tolerated dose levels and recommended doses; Parts 2 and 3 expand enrollment at selected doses to further study activity in metastatic urothelial carcinoma. Eligible participants generally have measurable disease, ECOG performance status 0–1, and have progressed on or after standard therapies including chemotherapy and PD-1/PD-L1 inhibitors (and enfortumab vedotin if applicable). Each participant’s involvement is approximately 17 months including screening (up to 21 days), about 5 months of treatment (variable), and around 11 months of follow-up.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Have received and progressed on, been intolerant to, or be ineligible for all available standard of care (SoC) therapies known to provide a survival and/or quality of life benefit for their tumor type. These therapies should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, enfortumab vedotin (EV), and other therapies, where applicable.
* Have measurable disease according to RECIST v1.1.
* Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.
* Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.
* Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).

Key Exclusion Criteria:

* Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.
* Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.
* Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.

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

Where it's running

• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• START New York Long Island LLC
  Lake Success, New York, United States Recruiting
• Carolina Urologic Research Center
  Myrtle Beach, South Carolina, United States Recruiting
• South Texas Accelerated Research Therapeutics
  San Antonio, Texas, United States Recruiting
• National Cancer Center Hospital
  Chuo Ku, Tokyo, Japan Recruiting
• Hospital HM Nou Delfos
  Barcelona, 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.