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RECRUITING
NCT07217171
PHASE1

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

Sponsor: EvolveImmune United, Inc

View on ClinicalTrials.gov

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

Interventions

DRUG

EVOLVE104

EVOLVE104 is provided as a solution for injection via IV infusion

DRUG

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