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NCT07193511PHASE1, PHASE2Recruiting

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)

Avenzo Therapeutics, Inc.

Start Date

10/2/2025

Completion Date

9/1/2030

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.

Detailed Description

Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-103 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-103 as a monotherapy. This data can guide selection of combination schedules and agents. Phase 2 is a dose expansion phase that will aim to assess the antitumor activity of AVZO-103 as a monotherapy and in combination therapy.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

AVZO-103

DRUG

Combination Agent

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Conditions

Solid Tumor CancerLocally AdvancedMetastatic Solid TumorsUrothelial Cancer

Locations

Avenzo Therapeutics Recruiting Site

San Francisco, California 94158

United States

Avenzo Therapeutics Recruiting Site

Aurora, Colorado 80045

United States

Avenzo Therapeutics Recruiting Site

Orlando, Florida 32827

United States

Avenzo Therapeutics Recruiting Site

Tampa, Florida 33612

United States

Avenzo Therapeutics Recruiting Site

Boston, Massachusetts 02114

United States

Avenzo Therapeutics Recruiting Site

New York, New York 10065

United States

Avenzo Therapeutics Recruiting Site

Chapel Hill, North Carolina 27514

United States

Avenzo Therapeutics Recruiting Site

Myrtle Beach, South Carolina 29572

United States

Avenzo Therapeutics Recruiting Site

Nashville, Tennessee 37203

United States

Avenzo Therapeutics Recruiting Site

Austin, Texas 78758

United States

Avenzo Therapeutics Recruiting Site

Irving, Texas 75039

United States