Study Evaluating AVZO-103 Alone and with Other Drugs in Adults with Advanced or Metastatic Urothelial Cancer and Solid Tumors

What this Trial Is About

Researchers are evaluating AVZO-103, a new investigational drug, for its safety, tolerability, how it behaves in the body, the highest dose that can be safely given, and its activity against tumors. This study involves adults with locally advanced or metastatic urothelial cancer or other solid tumors. The trial includes two phases Phase 1 focuses on finding the right dose and assessing safety, while Phase 2 aims to explore the drugs anti-cancer effects alone and in combination with other therapies. During Phase 1, participants receive escalating doses of AVZO-103 by intravenous infusion to determine the maximum tolerated dose and recommended dose for further study. Phase 2 expands to evaluate the drug both as a single agent and combined with other anti-cancer drugs, following protocols specifying doses and schedules. Treatments are given sequentially in these phases to study effects and safety. Participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and laboratory abnormalities over approximately two years. Tumor response, duration of response, disease control, and survival outcomes are evaluated throughout the study. Pharmacokinetics measurements will be taken to understand the drugs behavior in the body. The total participation may last up to several years, including follow-up to monitor treatment effects and safety.

BEACON-1: 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 (AVZO-103-1001)