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

NCT07217171 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-13

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • EvolveImmune United, Inc

    lead INDUSTRY

Principal Investigators

  • EvolveImmune Study Team · EvolveImmune United, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2029-01-29
Completion
2031-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217171 on ClinicalTrials.gov