RecruitingPhase 1NCT07217171

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

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


Sponsor

EvolveImmune United, Inc

Enrollment

160 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called EVOLVE104 for people with advanced cancers, specifically bladder cancer, squamous cell lung cancer, esophageal cancer, skin cancer, or cancers of the anal or genital area. Researchers are checking how safe and effective the drug is. **You may be eligible if...** - You have one of the following cancers that has spread or cannot be removed by surgery: bladder cancer, squamous cell lung cancer, esophageal cancer, skin squamous cell carcinoma, or anogenital squamous cell carcinoma - Your cancer has continued to grow or come back after standard treatments - Your cancer can be measured on a scan (CT or MRI) - You are generally functioning well day-to-day (ECOG score of 0 or 1) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - There is a targeted drug known to work for your specific cancer type - You have ongoing, significant side effects from prior cancer treatment - You have untreated, unstable brain metastases - You have a history of severe immune reactions to cancer treatments - You have significant heart disease, severe esophageal problems, or serious eye inflammation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEVOLVE104

EVOLVE104 is provided as a solution for injection via IV infusion

DRUGEVOLVE104

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

View Full Details on ClinicalTrials.gov

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NCT07217171


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