Clinical Trial

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas

Recruiting Phase 1
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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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2025-10-13; most recent amendment 2026-07-01.
Trial Details
NCT Number NCT07217171
Lead Sponsor EvolveImmune United, Inc
Conditions 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 Cell Carcinoma, Vulvar Squamous Cell Carcinoma +3 more
Enrollment 160 participants
Start Date 2025-11-13
Primary Completion 2029-01-29 (estimated)
Study Completion 2031-01-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-06