Brief Title: EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

Primary Outcome 1 - Timeframe: Baseline

Primary Outcome 2 - Measure: Number of patients with Dose Limiting Toxicities (DLTs)

Primary Outcome 2 - Timeframe: through study completion

Primary Outcome 3 - Measure: To determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) for EVOLVE104

Primary Outcome 3 - Timeframe: an average of 10 months.

Primary Outcome 4 - Measure: To determine the recommended phase 2 dose (RP2D) of EVOLVE104

Primary Outcome 4 - Timeframe: Baseline

CONDITION

• Bladder Cancer
• Squamous Cell Carcinoma of the Lung
• Esophageal Squamous Cell Carcinoma
• Tongue Squamous Cell Carcinoma
• Cutaneous Squamous Cell Cancer
• Penile Squamous Cell Carcinoma
• Anal Squamous Cell Carcinoma
• Vulvar Squamous Cell Carcinoma
• Cervical Squamous Cell Carcinoma
• Vaginal Squamous Cell Carcinoma
• Urethral Squamous Cell Carcinoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: EvolveImmune Study Team

Role: Study Director

Affiliation: EvolveImmune United, Inc

Overall Contact

Name: Evolve Study Team

Phone: 12032086584

Email: [email protected]

LOCATION