NCT07217171 · EvolveImmune United, Inc
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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 criteria
- 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.
Where
- Duarte, California
- Los Angeles, California
- New Haven, Connecticut
- Atlanta, Georgia
- Grand Rapids, Michigan
- New York, New York
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations