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Official Title

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

Phase
Phase 1
Sponsor
EvolveImmune United, Inc
Enrollment
160
Timeline
Nov 2025 → Jan 2031
About This 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.

Eligibility Criteria

Inclusion Criteria

  • 1Participants 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.
  • 2Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.
  • 3The cancer must be measurable by CT scan or MRI.
  • 4Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.
  • 5Anticipated life expectancy of at least 3 months.
  • 6Adequate organ function, as indicated by standard blood tests.
  • 7Able to provide a fresh or archival tumor biopsy.
  • 8Male 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.

Exclusion Criteria

  • 1The participant is a candidate for treatment with a targeted agent known to provide a benefit.
  • 2Persistent significant toxicities from prior anticancer therapy.
  • 3Brain metastases unless previously treated and stable.
  • 4Prior severe or life-threatening immunologic reactions to previous therapies.
  • 5Significant medical conditions, including but not limited to:
  • 6History of clinically significant cardiac disease
  • 7Severe esophageal disease such as esophageal rupture or severe erosive esophagitis.
  • 8Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations.
  • 9History of cirrhosis or significant portal hypertension.
  • 10Uncontrolled or significant infection.
  • 11History of certain other cancers in the past 3 years.
  • 12History of arterial thrombosis, stroke and transient ischemic attack within 6 months.
  • 13Active or uncontrolled HIV, HBV or HCV infection.
  • 14Autoimmune or other condition requiring chronic systemic immunosuppression.

Locations

4 sites participating in this study

The Winship Cancer Institute Emory University

Atlanta, Georgia 30322

Recruiting

START Midwest

Grand Rapids, Michigan 49546

Recruiting

SCRI

Nashville, Tennessee 37203

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →