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)

Part of paid clinical trials in San Francisco, California.

Sponsor
Avenzo Therapeutics, Inc.
Study ID
NCT07193511
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AVZO-103 — DRUG
    Specific dose in protocol specified schedule
  • Combination Agent — DRUG
    Per label based on combination agent used

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
355 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) [ Time Frame: Approximately 2 years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Avenzo Therapeutics Recruiting SiteSan FranciscoCalifornia94158-
Avenzo Therapeutics Recruiting SiteOrlandoFlorida32827-
Avenzo Therapeutics Recruiting SiteTampaFlorida33612-
Avenzo Therapeutics Recruiting SiteBostonMassachusetts02114-
Avenzo Therapeutics Recruiting SiteNew YorkNew York10065-
Avenzo Therapeutics Recruiting SiteChapel HillNorth Carolina27514-
Avenzo Therapeutics Recruiting SiteMyrtle BeachSouth Carolina29572-
Avenzo Therapeutics Recruiting SiteNashvilleTennessee37203-
Avenzo Therapeutics Recruiting SiteAustinTexas78758-
Avenzo Therapeutics Recruiting SiteIrvingTexas75039-

Find similar trials in San Francisco, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Avenzo Therapeutics Recruiting Site· San Francisco, CAAvenzo Therapeutics Recruiting Site· Orlando, FLAvenzo Therapeutics Recruiting Site· Tampa, FLAvenzo Therapeutics Recruiting Site· Boston, MAAvenzo Therapeutics Recruiting Site· New York, NYAvenzo Therapeutics Recruiting Site· Chapel Hill, NC

Related Studies