N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: EvolveImmune United, Inc • ClinicalTrials.gov ID: NCT07217171

Registry updated: 2026-09-15
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • EVOLVE104 (Drug)
    EVOLVE104 is provided as a solution for injection via IV infusion
  • EVOLVE104 (Drug)
    Dose levels for Phase 1b will be determined based on the outcome of Phase 1a

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.

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

Locations

  • City of Hope — Duarte, California, United States
  • USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • UCSF Medical center Parnassus — San Francisco, California, United States
  • Yale University Cancer Center — New Haven, Connecticut, United States
  • The Winship Cancer Institute Emory University — Atlanta, Georgia, United States
  • START Midwest — Grand Rapids, Michigan, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Columbia University Irving Medical Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Duke University Medical Center - Duke Cancer Center — Durham, North Carolina, United States
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
  • Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
  • SCRI — Nashville, Tennessee, United States
  • Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • Virginia Cancer Specialists — Fairfax, Virginia, United States
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record