Brief Title: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)

Primary Outcome 1 - Timeframe: Approximately 2 years

Primary Outcome 2 - Measure: Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)

Primary Outcome 2 - Timeframe: Approximately 16 months

Primary Outcome 3 - Measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)

Primary Outcome 3 - Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)

Primary Outcome 4 - Measure: Objective Response Rate (ORR) (Phase 2)

Primary Outcome 4 - Timeframe: From baseline through disease progression or study completion (approximately 2 years)

CONDITION

• Solid Tumor Cancer
• Locally Advanced
• Metastatic Solid Tumors
• Urothelial Cancer

ELIGIBILITY

Key Inclusion Criteria:
* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of > 3 months.

- * Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications:
o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).

- * Measurable disease as assessed by Investigator using RECIST v1.1.

- * Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.

- * Other protocol-defined Inclusion criteria apply.
Key Exclusion Criteria:
* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.

- * Prior Stevens-Johnson syndrome/toxic epidermal necrolysis.

- * History of drug-induced interstitial lung disease (ILD).

- * History of any serious cardiovascular condition.

- * Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.

- * History of allogenic stem cell or solid organ transplant.

- * Other protocol-defined Exclusion criteria apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Medical Information

Phone: (858) 239-2944

Email: [email protected]

LOCATION