Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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