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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: EvolveImmune United, Inc · Participants: 160 · Started: Nov 13, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07217171

Locations in the U.S.

CaliforniaCity of Hope, Duarte
USC/Norris Comprehensive Cancer Center, Los Angeles
UCSF Medical center Parnassus, San Francisco
ConnecticutYale University Cancer Center, New Haven
GeorgiaThe Winship Cancer Institute Emory University, Atlanta
MichiganSTART Midwest, Grand Rapids
New YorkColumbia University Irving Medical Center, New York
Icahn School of Medicine at Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
North CarolinaDuke University Medical Center - Duke Cancer Center, Durham
OhioUniversity Hospitals Cleveland Medical Center, Cleveland
PennsylvaniaThomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia
TennesseeSCRI, Nashville
Vanderbilt-Ingram Cancer Center, Nashville
TexasMD Anderson Cancer Center, Houston
VirginiaVirginia Cancer Specialists, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.