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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)

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Avenzo Therapeutics, Inc. · Participants: 355 · Started: Oct 2, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07193511

Locations in the U.S.

CaliforniaAvenzo Therapeutics Recruiting Site, San Francisco
ColoradoAvenzo Therapeutics Recruiting Site, Aurora
ConnecticutAvenzo Therapeutics Recruiting Site, New Haven
FloridaAvenzo Therapeutics Recruiting Site, Orlando
Avenzo Therapeutics Recruiting Site, Tampa
MassachusettsAvenzo Therapeutics Recruiting Site, Boston
New YorkAvenzo Therapeutics Recruiting Site, New York
North CarolinaAvenzo Therapeutics Recruiting Site, Chapel Hill
OhioAvenzo Therapeutics Recruiting Site, Cleveland
South CarolinaAvenzo Therapeutics Recruiting Site, Myrtle Beach
TennesseeAvenzo Therapeutics Recruiting Site, Nashville
TexasAvenzo Therapeutics Recruiting Site, Austin
Avenzo Therapeutics Recruiting Site, Houston
Avenzo Therapeutics Recruiting Site, Irving

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.