RecruitingPhase 1NCT07217171

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

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.

Checked against the public recordLast updated Aug 28, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations15
SponsorEvolveImmune United, Inc
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
EvolveImmune United, Inc
Interventions being studied
Drug: EVOLVE104; Drug: EVOLVE104
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: Participants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma. 1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type. 2. The cancer must be measurable by CT scan or MRI. 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1. 4. Anticipated life expectancy of at least 3 months. 5. Adequate organ function, as indicated by standard blood tests. 6. Able to provide a fresh or archival tumor biopsy. 7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile. Key Exclusion Criteria: 1. The participant is a candidate for treatment with a targeted agent known to provide a benefit. 2. Persistent significant toxicities from prior anticancer therapy. 3. Brain metastases unless previously treated and stable. 4. Prior severe or life-threatening immunologic reactions to previous therapies. 5. Significant medical conditions, including but not limited to: * History of clinically significant cardiac disease * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis. * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations. * History of cirrhosis or significant portal hypertension. * Uncontrolled or significant infection. * History of certain other cancers in the past 3 years. * History of arterial thrombosis, stroke and transient ischemic attack within 6 months. * Active or uncontrolled HIV, HBV or HCV infection. * Autoimmune or other condition requiring chronic systemic immunosuppression.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • City of HopeDuarte, California
  • USC/Norris Comprehensive Cancer CenterLos Angeles, California
  • UCSF Medical center ParnassusSan Francisco, California
  • Yale University Cancer CenterNew Haven, Connecticut
  • The Winship Cancer Institute Emory UniversityAtlanta, Georgia
  • START MidwestGrand Rapids, Michigan
  • Icahn School of Medicine at Mount SinaiNew York, New York
  • Columbia University Irving Medical CenterNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania
  • SCRINashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 28, 2026. Always confirm current availability with the study team.

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