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) (AVZO-103-1001)

August 24, 2026 updated by: Avenzo Therapeutics, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

355

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2, monotherapy
Part A
Drug: AVZO-103
Specific dose in protocol specified schedule
Experimental: Phase 2, combination
Part B
Drug: AVZO-103
Specific dose in protocol specified schedule
Drug: Combination Agent
Per label based on combination agent used
Experimental: Phase 1, monotherapy
Part A
Drug: AVZO-103
Specific dose in protocol specified schedule
Experimental: Phase 1, combination
Part B
Drug: AVZO-103
Specific dose in protocol specified schedule
Drug: Combination Agent
Per label based on combination agent used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
Time Frame: From baseline until end of study treatment or study completion (approximately 2 years)
From baseline until end of study treatment or study completion (approximately 2 years)
Objective Response Rate (ORR) (Phase 2)
Time Frame: From baseline through disease progression or study completion (approximately 2 years)
Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
From baseline through disease progression or study completion (approximately 2 years)
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Time Frame: Approximately 2 years
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Approximately 2 years
Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)
Time Frame: Approximately 16 months
Approximately 16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) (Phase 1)
Time Frame: From baseline through disease progression or study completion (approximately 2 years)
From baseline through disease progression or study completion (approximately 2 years)
Determination of RP2D (Phase 2)
Time Frame: Approximately 16 months
Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)
Time Frame: From baseline until end of study treatment or study completion (approximately 2 years)
From baseline until end of study treatment or study completion (approximately 2 years)
Duration of Response (DOR) (Phase 1 and 2)
Time Frame: From baseline through disease progression or study completion (approximately 2 years)
Defined as the time from the first confirmed response to radiologic/objective progression.
From baseline through disease progression or study completion (approximately 2 years)
Progression Free Survival (PFS) (Phase 1 and 2)
Time Frame: From baseline through time to event on study or study completion (approximately 2 years)
Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
From baseline through time to event on study or study completion (approximately 2 years)
Overall Survival (OS) (Phase 1 and 2)
Time Frame: Approximately 76 months
Defined as the time from study drug treatment initiation to death from any cause.
Approximately 76 months
PK Parameters: Maximum observed concentration (Cmax) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Minimum observed concentration (Cmin) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Elimination half-life (T1/2) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Apparent Clearance (CL/F) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
PK Parameters: Accumulation ratio (AR) (Phase 1)
Time Frame: Up to 2 years
Up to 2 years
Disease Control Rate (DCR) (Phase 1 and 2)
Time Frame: From baseline through disease progression or study completion (approximately 2 years)
Defined as the proportion of patients who achieve tumor response (CR or PR) and stable disease (SD) after treatment; calculated as the sum of CR, PR, and SD.
From baseline through disease progression or study completion (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avenzo Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2025

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

September 24, 2025

First Posted (Actual)

September 26, 2025

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVZO-103-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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