Actively Recruiting
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
Led by EvolveImmune United, Inc · Updated on 2026-06-03
160
Participants Needed
10
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying EVOLVE104 in adults with advanced urothelial and squamous cell carcinomas who have either received standard treatments without success, declined those treatments, or were ineligible for them. This phase 1a/1b clinical trial aims to assess the safety, tolerability, and how the body processes EVOLVE104, a drug given by intravenous infusion, in participants with various advanced solid tumors including bladder, lung, esophageal, tongue, skin, and anogenital squamous cell cancers. The study includes a dose-escalation phase followed by a dose-expansion phase with two cohorts, depending on initial safety and effectiveness data. Participants will receive EVOLVE104 in different dose levels during the phase 1a dose-escalation stage, with doses adjusted to find the maximum tolerated dose and recommended phase 2 dose. Phase 1b will include up to two expansion cohorts with doses based on findings from phase 1a. Treatment continues until disease progression, adverse events, participant or investigator decision to stop, withdrawal of consent, or death, with an expected duration of about 10 months. During the study, participants undergo regular safety evaluations, including monitoring for treatment-emergent adverse events and dose-limiting toxicities. Pharmacokinetics and pharmacodynamics assessments occur each 28-day cycle with blood samples taken before and after dosing. Tumor measurements are done by CT or MRI scans. Researchers also monitor anti-drug antibodies and track efficacy signals. Participants must provide tumor biopsies and meet specific health criteria to join. The study may last up to 10 months per participant, with ongoing safety and response assessments throughout.
CONDITIONS
Brief Title
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have locally advanced or metastatic bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma
- Documented disease progression during or after standard treatment depending on tumor type
- Cancer must be measurable by CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Anticipated life expectancy of at least 3 months
- Adequate organ function based on 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 last dose, except women who are post-menopausal or surgically sterile
You will not qualify if you...
- Candidate for treatment with a targeted agent known to provide benefit
- Persistent significant toxicities from prior anticancer therapy
- Brain metastases unless previously treated and stable
- Prior severe or life-threatening immune reactions to previous therapies
- Significant medical conditions including:
- History of serious cardiac disease
- Severe esophageal disease such as rupture or erosive esophagitis
- Active inflammatory corneal or conjunctival problems
- History of cirrhosis or significant portal hypertension
- Uncontrolled or significant infection
- History of certain other cancers within past 3 years
- Recent arterial thrombosis, stroke, or transient ischemic attack within 6 months
- Active or uncontrolled HIV, HBV, or HCV infection
- Autoimmune or other conditions needing chronic systemic immunosuppression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 months
Participants receive EVOLVE104 through intravenous infusion in repeated 28-day cycles until disease progression, adverse events, or other discontinuation criteria are met.
Visits each cycle (28 days) for treatment and assessments
Trial Site Locations
Total: 10 locations
1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Yale University Cancer Center
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
The Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
8
SCRI
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
E
Evolve Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
12
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