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

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

This trial tests a new drug called GEN1106 in people with metastatic solid tumors, especially urothelial (bladder) cancer, who have progressed after standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 103 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Genmab (industry)
• Drugs / interventions: enfortumab, chemotherapy
• Locations: 4 sites (Lake Success, New York and 3 other locations)
• Trial ID: NCT07416123 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with measurable metastatic solid tumors—particularly metastatic urothelial carcinoma—who have ECOG performance status 0–1 and have progressed on or after standard therapies including chemotherapy and PD-1/PD-L1 therapies are the intended candidates.

Not a fit: Patients who previously received topoisomerase-1 inhibitor–based ADCs, those with ECOG >1, or those without measurable disease per RECIST v1.1 may not qualify or are less likely to benefit.

Why it matters

Potential benefit: If successful, GEN1106 could provide a new treatment option for patients with metastatic urothelial carcinoma and other solid tumors who have exhausted standard therapies.

How similar studies have performed: Other antibody-drug conjugates and targeted agents have shown responses in urothelial cancer, but GEN1106 is a first-in-human agent and its safety and effectiveness in people remain unproven.

Eligibility criteria

Key Inclusion Criteria:

* Have progressed on or after standard of care (SoC) therapy, which should include chemotherapy, anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) therapies, and enfortumab vedotin (EV), if applicable for the tumor type, or for whom there is no available standard therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1106 may be beneficial, in the opinion of the investigator.
* 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 this trial is running

Lake Success, New York and 3 other locations

• 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)

Study contacts

• Study coordinator: Genmab Trial Information

Conditions: Solid Tumors, Urothelial Carcinoma