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)

ClinicalTrials.gov ID: NCT07193511

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07193511
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Avenzo Therapeutics, Inc.; Industry
Enrollment: 355 participants

Conditions and interventions

Conditions

Interventions

AVZO-103 Drug
Combination Agent Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2, 2025 (Actual)
Primary completion: Mar 2030 (Estimated)
Completion: Sep 2030 (Estimated)
Last update posted: Oct 5, 2026

2025 – 2030

United States locations

U.S. sites: 15
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Avenzo Therapeutics Recruiting Site	San Francisco	California	94158	Recruiting
Avenzo Therapeutics Recruiting Site	Aurora	Colorado	80045	Recruiting
Avenzo Therapeutics Recruiting Site	New Haven	Connecticut	06519	Recruiting
Avenzo Therapeutics Recruiting Site	Orlando	Florida	32827	Recruiting
Avenzo Therapeutics Recruiting Site	Tampa	Florida	33612	Recruiting
Avenzo Therapeutics Recruiting Site	Boston	Massachusetts	02114	Recruiting
Avenzo Therapeutics Recruiting Site	New York	New York	10065	Recruiting
Avenzo Therapeutics Recruiting Site	Chapel Hill	North Carolina	27514	Recruiting
Avenzo Therapeutics Recruiting Site	Cleveland	Ohio	44106	Recruiting
Avenzo Therapeutics Recruiting Site	Oklahoma City	Oklahoma	73104	Recruiting
Avenzo Therapeutics Recruiting Site	Myrtle Beach	South Carolina	29572	Recruiting
Avenzo Therapeutics Recruiting Site	Nashville	Tennessee	37203	Recruiting
Avenzo Therapeutics Recruiting Site	Austin	Texas	78758	Recruiting
Avenzo Therapeutics Recruiting Site	Houston	Texas	77030	Recruiting
Avenzo Therapeutics Recruiting Site	Irving	Texas	75039	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07193511, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 5, 2026 · Synced Nov 15, 2026