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

Active:	Yes
Cancer Type:	Bladder Cancer Esophogeal Cancer	NCT ID:	NCT07217171
Trial Phases:	Phase I	Protocol IDs:	EIU-104101 (primary) Drug: EVOLVE104
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	EvolveImmune United, Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT07217171

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.