A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas

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.