Recruiting

Phase 1

Phase 2

AVZO-103BEACON-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)

Sponsor:

Avenzo Therapeutics, Inc.

Code:

NCT07193511

Conditions

Solid Tumor Cancer

Locally Advanced

Metastatic Solid Tumors

Urothelial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AVZO-103

Combination Agent

Study Details

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.

Conditions

Solid Tumor Cancer

Locally Advanced

Metastatic Solid Tumors

Urothelial Cancer

Study ID

NCT07193511

Start date

Oct 2, 2025

Status verified date

Nov, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

355 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1, monotherapy

Part A

experimental: Phase 1, combination

Part B

experimental: Phase 2, monotherapy

Part A

experimental: Phase 2, combination

Part B

Interventions

AVZO-103

Specific dose in protocol specified schedule

Combination Agent

Per label based on combination agent used

Primary outcome measure

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) [ Time Frame: Approximately 2 years ]
Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1) [ Time Frame: Approximately 16 months ]
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) ]
Objective Response Rate (ORR) (Phase 2) [ Time Frame: From baseline through disease progression or study completion (approximately 2 years) ]

Central Contacts and Locations

Central contacts

Medical Information

(858) 239-2944 ClinicalTrials@avenzotx.com

Locations