Tests EVOLVE104 in adults with advanced bladder and squamous cell cancers
Tests EVOLVE104, a new drug, in adults with advanced squamous cell or bladder cancers.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Key facts
- Where
- Atlanta, Cleveland, Duarte, Durham, Fairfax, Grand Rapids, Houston, Los Angeles, Nashville, New Haven, New York, Philadelphia, and San Francisco, United StatesSee the 16 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic bladder cancer or squamous cell cancer whose disease got worse during or after standard treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic bladder cancer, or squamous cell carcinoma of the lung, esophagus, skin, or anogenital area. The cancer must be measurable by CT scan or MRI.
- Earlier treatment
- The disease must have gotten worse during or after standard treatment for the tumor type.
Main reasons for not taking part
- Candidate for a targeted drug known to give a benefit
- Brain metastases, unless already treated and stable
- Significant heart disease or severe esophageal disease
- Active inflammation, erosion or ulcers of the cornea or conjunctiva
- Active or uncontrolled HIV, HBV or HCV infection
Read by machine on 9 November 2026.
Where in United States
- The Winship Cancer Institute Emory UniversityAtlanta, United StatesTaking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
- City of HopeDuarte, United StatesTaking people
- Duke University Medical Center - Duke Cancer CenterDurham, United StatesTaking people
- Virginia Cancer SpecialistsFairfax, United StatesTaking people
- START | MidwestGrand Rapids, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- SCRINashville, United StatesTaking people
- Vanderbilt-Ingram Cancer CenterNashville, United StatesTaking people
- Yale University - Cancer CenterNew Haven, United StatesTaking people
- Columbia University Irving Medical CenterNew York, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, United StatesTaking people
- UCSF Medical Center-ParnassusSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EvolveImmune United, Inc
- Trial code
- NCT07217171
- Record updated
- 15 September 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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.
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.