EVOLVE104 for advanced bladder and other squamous cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human phase 1a/1b trial uses a dose-escalation stage followed by a dose-expansion stage to study safety, tolerability, and pharmacokinetics of EVOLVE104 in people with advanced, relapsed, or refractory urothelial and squamous cell carcinomas. Phase 1a will identify safe dose levels, and Phase 1b may open up to two expansion cohorts based on safety and early signals. The study plans to enroll about 160 participants across the two stages, treating participants until disease progression or other discontinuation criteria. Key procedures include imaging to document measurable disease and fresh or archival tumor biopsies for correlative testing.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• UCSF Medical center Parnassus
  San Francisco, California, United States Recruiting
• Yale University Cancer Center
  New Haven, Connecticut, United States Recruiting
• The Winship Cancer Institute Emory University
  Atlanta, Georgia, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Evolve Study Team
• Email: Evolve104Study@evolveimmune.com
• Phone: 12032086584

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.