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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
Trial Status: active
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 Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07217171.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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 solid tumors, including bladder, lung, esophageal,
tongue, cutaneous and anogenital squamous cell carcinomas. This study consists of Phase
1a dose-escalation stage followed by a Phase 1b dose expansion stage featuring 2
expansion cohorts that may be opened, at the Sponsor's discretion, depending on the
safety, efficacy, and other observations from Phase 1a.
This study is anticipated to enroll approximately 160 participants: up to 80 participants
in Phase 1a, and up to 80 participants in Phase 1b.
Participants will be treated until they meet treatment discontinuation criteria,
including disease progression, adverse events (AEs), subject decision, investigator
decision, withdrawal of consent, death. The expected duration of treatment in this study
is approximately 10 months based on the anticipated progression rates for the represented
