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)
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
Sponsor: Avenzo Therapeutics, Inc.
This observational or N/A phase trial investigates Locally Advanced and Metastatic Solid Tumors and is currently actively recruiting participants. Avenzo Therapeutics, Inc. leads this study, which shows 5 recorded versions since 2025 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
5 versions recorded-
Apr 17, 2026 — Present [daily]
Recruiting
Phase: PHASE1/PHASE2 → None
-
Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE1/PHASE2
-
Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE1/PHASE2
-
Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE1/PHASE2
Status: Not Yet Recruiting → Recruiting
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Oct 2025 — Nov 2025 [monthly]
Not Yet Recruiting PHASE1/PHASE2
First recorded
Eligibility 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.
Contact Information
- Avenzo Therapeutics, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .