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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Sponsor: EvolveImmune United, Inc
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.
Official title: A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-11-13
Completion Date
2031-01-29
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
EVOLVE104
EVOLVE104 is provided as a solution for injection via IV infusion
EVOLVE104
Dose levels for Phase 1b will be determined based on the outcome of Phase 1a
Locations (9)
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Yale University Cancer Center
New Haven, Connecticut, United States
The Winship Cancer Institute Emory University
Atlanta, Georgia, United States
START Midwest
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
SCRI
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States