RecruitingPhase 1NCT07217171
Official study title

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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEVOLVE104 and EVOLVE104

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?16 U.S. locations

Locations may change over time.

Who runs it?EvolveImmune United, Inc

Study sponsor

01
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
02
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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key 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

Reasons someone may not be able to joinExclusion 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.

04
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
  • Duke University Medical Center - Duke Cancer CenterDurham, North Carolina
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 15, 2026. Always confirm current availability with the study team.

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