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RECRUITING
NCT07193511
PHASE1/PHASE2

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)

Sponsor: Avenzo Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.

Official title: A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4/Trop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

355

Start Date

2025-10-02

Completion Date

2030-09

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

AVZO-103

Specific dose in protocol specified schedule

DRUG

Combination Agent

Per label based on combination agent used

Locations (8)

Avenzo Therapeutics Recruiting Site

Orlando, Florida, United States

Avenzo Therapeutics Recruiting Site

Boston, Massachusetts, United States

Avenzo Therapeutics Recruiting Site

New York, New York, United States

Avenzo Therapeutics Recruiting Site

Chapel Hill, North Carolina, United States

Avenzo Therapeutics Recruiting Site

Myrtle Beach, South Carolina, United States

Avenzo Therapeutics Recruiting Site

Nashville, Tennessee, United States

Avenzo Therapeutics Recruiting Site

Austin, Texas, United States

Avenzo Therapeutics Recruiting Site

Irving, Texas, United States