Status:
RECRUITING
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Lead Sponsor:
EvolveImmune United, Inc
Conditions:
Bladder Cancer
Squamous Cell Carcinoma of the Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 optio...
Detailed Description
This is a dose-escalation and expansion First in Human phase 1a/1b study evaluating safety, tolerability, and pharmacokinetics (PK) of EVOLVE104 in participants with advanced, relapsed or refractory s...
Eligibility Criteria
Inclusion
- 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.
- Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.
- The cancer must be measurable by CT scan or MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.
- Anticipated life expectancy of at least 3 months.
- Adequate organ function, as indicated by standard blood tests.
- Able to provide a fresh or archival tumor biopsy.
- 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
- The participant is a candidate for treatment with a targeted agent known to provide a benefit.
- Persistent significant toxicities from prior anticancer therapy.
- Brain metastases unless previously treated and stable.
- Prior severe or life-threatening immunologic reactions to previous therapies.
- 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.
Key Trial Info
Start Date :
November 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2031
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07217171
Start Date
November 13 2025
End Date
January 29 2031
Last Update
December 30 2025
Active Locations (4)
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1
The Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
2
START Midwest
Grand Rapids, Michigan, United States, 49546
3
SCRI
Nashville, Tennessee, United States, 37203
4
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031