Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07193511

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)

Led by Avenzo Therapeutics, Inc. · Updated on 2026-04-16

355

Participants Needed

9

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years and older with an ECOG Performance Status of 0 or 1 and life expectancy over 3 months
  • Histologically or cytologically confirmed locally advanced or metastatic urothelial cancer or other specified solid tumors
  • Measurable disease according to RECIST v1.1 criteria
  • Willingness to provide molecular test results and tumor samples or fresh biopsy
  • Meet other protocol-defined inclusion criteria
Not Eligible

You will not qualify if you...

  • Active central nervous system metastases; stable, treated brain metastases allowed if stable for at least 4 weeks without steroids
  • Suspected or confirmed leptomeningeal disease
  • History of Stevens-Johnson syndrome or toxic epidermal necrolysis
  • History of drug-induced interstitial lung disease
  • History of serious cardiovascular conditions
  • Infection requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before first dose
  • History of allogenic stem cell or solid organ transplant
  • Meet other protocol-defined exclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 9 locations

1

Avenzo Therapeutics Recruiting Site

Orlando, Florida, United States, 32827

Actively Recruiting

2

Avenzo Therapeutics Recruiting Site

Tampa, Florida, United States, 33612

Actively Recruiting

3

Avenzo Therapeutics Recruiting Site

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Avenzo Therapeutics Recruiting Site

New York, New York, United States, 10065

Actively Recruiting

5

Avenzo Therapeutics Recruiting Site

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

6

Avenzo Therapeutics Recruiting Site

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

7

Avenzo Therapeutics Recruiting Site

Nashville, Tennessee, United States, 37203

Actively Recruiting

8

Avenzo Therapeutics Recruiting Site

Austin, Texas, United States, 78758

Actively Recruiting

9

Avenzo Therapeutics Recruiting Site

Irving, Texas, United States, 75039

Actively Recruiting

Loading map...

Research Team

M

Medical Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here