NCT07217171

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: EvolveImmune United, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Squamous Cell Carcinoma of the Lung
• Esophageal Squamous Cell Carcinoma
• Tongue Squamous Cell Carcinoma
• Cutaneous Squamous Cell Cancer
• Penile Squamous Cell Carcinoma
• Anal Squamous Cell Carcinoma
• Vulvar Squamous Cell Carcinoma
• Cervical Squamous Cell Carcinoma
• Vaginal Squamous Cell Carcinoma
• Urethral Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-13
• Primary completion: 2029-01-29
• Completion: 2031-01-29
• First posted: 2025-10-15
• Last updated: 2026-04-13

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study