A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Partici
The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic
| Condition(s) | Bladder Cancer, Squamous Cell Carcinoma of the Lung, Esophageal Squamous Cell Carcinoma, Tongue Squamous Cell Carcinoma, Cutaneous Squamous Cell Cancer, Penile Squamous Cell Carcinoma, Anal Squamous C |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study. |
| Who can participate | Key Inclusion Criteria: Participants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma. 1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type. 2. The cancer must be measurable by CT scan or MRI. 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1. 4. Anticipated life expectancy of at least 3 months. 5. Adequate organ function, as indicated by standard blood tests. 6. Able to provide a fresh or archival tumor biopsy. 7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, ex |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | EvolveImmune United, Inc |
| Locations | Los Angeles, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Grand Rapids, Michigan, United States; New York, New York, United States; New York, New York, United States (+4 more sites) |
| Start date | 2025-11-13 |
| NCT ID | NCT07217171 |
| Official listing | https://clinicaltrials.gov/study/NCT07217171 |