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BEACON-1 Study for Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

This study, called BEACON-1, is the first clinical trial for a drug named AVZO-103. It's looking at how safe and effective AVZO-103 is when given alone or with another treatment to people with locally advanced (cancer that has grown into nearby tissues) or metastatic (cancer that has spread to other parts of the body) urothelial cancer or other solid tumors. The study will also help determine the best dose of AVZO-103. You might be able to join if you are an adult with one of these cancer types, have a good performance status, and a life expectancy of more than 3 months. The study aims to enroll 355 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with two phases. Phase 1 will determine the maximum tolerated dose, and Phase 2 will assess the drug's activity.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events and lab abnormalities from baseline until the end of study treatment or study completion, which is approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07193511

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Avenzo Therapeutics, Inc.
~355 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:AVZO-103Combination Agent

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Measured over Approximately 2 years
+3 more outcomes measured

Conditions

Solid Tumor Cancer
Locally Advanced
Metastatic Solid Tumors
Urothelial Cancer

Explore related trials

Solid NeoplasmUrothelial Carcinoma

Where it's being run

14 sites across 11 states
Texas3
Florida2
California1
Colorado1
Connecticut1
Massachusetts1
New York1
North Carolina1

Who to contact

Medical Information
[email protected]
(858) 239-2944
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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.

Exclusion

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.

What this trial measures

  • 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.