A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Start Date
11/13/2025
Completion Date
1/29/2031
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.
Detailed Description
This is a dose-escalation and expansion First in Human phase 1a/1b study evaluating safety, tolerability, and pharmacokinetics (PK) of EVOLVE104 in participants with advanced, relapsed or refractory solid tumors, including bladder, lung, esophageal, tongue, cutaneous and anogenital squamous cell carcinomas. This study consists of Phase 1a dose-escalation stage followed by a Phase 1b dose expansion stage featuring 2 expansion cohorts that may be opened, at the Sponsor's discretion, depending on the safety, efficacy, and other observations from Phase 1a. This study is anticipated to enroll approximately 160 participants: up to 80 participants in Phase 1a, and up to 80 participants in Phase 1b. Participants will be treated until they meet treatment discontinuation criteria, including disease progression, adverse events (AEs), subject decision, investigator decision, withdrawal of consent, death. The expected duration of treatment in this study is approximately 10 months based on the anticipated progression rates for the represented malignancies.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
EVOLVE104
EVOLVE104
Conditions
Locations
City of Hope
Duarte, California 91010
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Yale University Cancer Center
New Haven, Connecticut 06511
United States
The Winship Cancer Institute Emory University
Atlanta, Georgia 30322
United States
START Midwest
Grand Rapids, Michigan 49546
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
SCRI
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States