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Clinical Trials in the USA / NCT07193511
Recruiting Phase 1/2

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)

NCT07193511 · tracked via the Priya Life Science USA tracker
Sponsor
Avenzo Therapeutics, Inc
Phase
Phase 1/2
Started
2025-10-02
Last updated
2026-10-05

Condition(s) studied

Solid Tumor CancerLocally AdvancedMetastatic Solid TumorsUrothelial Cancer

Investigational drug(s) / intervention(s)

AVZO-103Combination Agent

AVZO-103: Specific dose in protocol specified schedule

Combination Agent: Per label based on combination agent used

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) — Approximately 2 years
    Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
  • 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) — 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.

Trial sites (15)

FacilityCityRegionStatus
Avenzo Therapeutics Recruiting Site San Francisco California Recruiting
Avenzo Therapeutics Recruiting Site Aurora Colorado Recruiting
Avenzo Therapeutics Recruiting Site New Haven Connecticut Recruiting
Avenzo Therapeutics Recruiting Site Orlando Florida Recruiting
Avenzo Therapeutics Recruiting Site Tampa Florida Recruiting
Avenzo Therapeutics Recruiting Site Boston Massachusetts Recruiting
Avenzo Therapeutics Recruiting Site New York New York Recruiting
Avenzo Therapeutics Recruiting Site Chapel Hill North Carolina Recruiting
Avenzo Therapeutics Recruiting Site Cleveland Ohio Recruiting
Avenzo Therapeutics Recruiting Site Oklahoma City Oklahoma Recruiting
Avenzo Therapeutics Recruiting Site Myrtle Beach South Carolina Recruiting
Avenzo Therapeutics Recruiting Site Nashville Tennessee Recruiting
Avenzo Therapeutics Recruiting Site Austin Texas Recruiting
Avenzo Therapeutics Recruiting Site Houston Texas Recruiting
Avenzo Therapeutics Recruiting Site Irving Texas Recruiting

More Avenzo Therapeutics, Inc. trials in the USA

ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors Recruiting
AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001) Recruiting
Study of AVZO-021 in Patients With Advanced Solid Tumors Recruiting

Other trials for the same condition

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer Active, not recruiting
A Study of DS3610a in Participants With Advanced Solid Tumor Recruiting
A Study of MGC030 in Participants With Advanced Solid Tumors Recruiting
SLR-108 PET Imaging in Subjects With Metastatic Solid Tumors Recruiting
A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07193511 on ClinicalTrials.gov ↗ ← All trials in the USA