NCT07193511|RecruitingPhase 1FDA Drug

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

Avenzo Therapeutics, Inc.ClinicalTrials.gov

Compare

1 other identifier

AVZO-103-1001

Study Type

interventional

Target

355

Locations

1 country

Sites

Timeline

RegisteredSep 2025

StartedOct 2025

CompletionSep 2030

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

355

participants targeted

Target at P75+ for phase_1

Timeline

53mo left

Started Oct 2025

Longer than P75 for phase_1

Geographic Reach

1 country

9 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

Study Progress12%

Oct 2025Sep 2030

First Submitted

Initial submission to the registry

September 24, 2025

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed

6 days until next milestone

Study Start

First participant enrolled

October 2, 2025

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

April 16, 2026

Status Verified

November 1, 2025

Enrollment Period

4.4 years

First QC Date

September 24, 2025

Last Update Submit

April 15, 2026

Conditions

Metastatic Solid Tumors Locally Advanced Solid Tumor Cancer Urothelial Cancer

Keywords

Solid TumorsMetastaticLocally AdvancedUrothelial Cancer

Outcome Measures

Primary Outcomes (4)

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
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)
Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
From baseline until end of study treatment or study completion (approximately 2 years)
Objective Response Rate (ORR) (Phase 2)
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)

Secondary Outcomes (17)

Objective Response Rate (ORR) (Phase 1)
From baseline through disease progression or study completion (approximately 2 years)
Duration of Response (DOR) (Phase 1 and 2)
From baseline through disease progression or study completion (approximately 2 years)
Disease Control Rate (DCR) (Phase 1 and 2)
From baseline through disease progression or study completion (approximately 2 years)
Progression Free Survival (PFS) (Phase 1 and 2)
From baseline through time to event on study or study completion (approximately 2 years)
Overall Survival (OS) (Phase 1 and 2)
Approximately 76 months
+12 more secondary outcomes

Study Arms (4)

Phase 1, monotherapy

EXPERIMENTAL

Part A

Drug: AVZO-103

Phase 1, combination

EXPERIMENTAL

Part B

Drug: AVZO-103Drug: Combination Agent

Phase 2, monotherapy

EXPERIMENTAL

Part A

Drug: AVZO-103

Phase 2, combination

EXPERIMENTAL

Part B

Drug: AVZO-103Drug: Combination Agent

Interventions

Combination AgentDRUG

Per label based on combination agent used

Phase 1, combinationPhase 2, combination

AVZO-103DRUG

Specific dose in protocol specified schedule

Phase 1, combinationPhase 1, monotherapyPhase 2, combinationPhase 2, monotherapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.