A Phase 1/2 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

What this Trial Is About

Researchers are evaluating AVZO-103, a Nectin4/Trop2 antibody-drug conjugate, in patients with locally advanced or metastatic urothelial cancer and other solid tumors. This first clinical trial aims to study the safety, tolerability, how the body processes the drug, the maximum dose patients can tolerate, and its antitumor activity when given alone or with other treatments. The trial includes both Phase 1 and Phase 2 parts to explore these factors in detail. The study starts with a Phase 1 dose escalation phase to find the safest and most effective dose of AVZO-103 as a single treatment and to guide combination therapy plans. Phase 2 expands to assess antitumor activity of AVZO-103 alone and combined with other drugs. Treatments are given intravenously according to protocol schedules, with specific doses and combinations tested in different study parts. Participants will be closely monitored throughout the study, which lasts approximately two years for most measures and up to 76 months for overall survival tracking. Assessments include safety evaluations, adverse event monitoring, laboratory tests, and imaging to measure tumor response. Researchers will collect pharmacokinetic data and other measures to understand how the drug acts in the body. Study visits and tests occur regularly from baseline through disease progression or study completion.

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)