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NCT07193511 · ClinicalTrials.gov registry record · Phase 1
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 study of Urothelial Cancer and Metastatic Solid Tumors, sponsored by Avenzo Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 355
- Enrollment target
- 6
- Study locations
NCT07193511: Recruiting Phase 1 study of Urothelial Cancer and Metastatic Solid Tumors, sponsored by Avenzo Therapeutics.
NCT07193511 is a Phase 1 study of Urothelial Cancer and Metastatic Solid Tumors that is actively recruiting participants, run by Avenzo Therapeutics. The registered enrollment target is 355 participants, below the 560-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (37% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07193511, a Phase 1 study of Urothelial Cancer and Metastatic Solid Tumors, is actively recruiting participants, sponsored by Avenzo Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 355 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Conditions Studied
Interventions
- DRUG AVZO-103
- DRUG Combination Agent
Study Locations (6)
Texas
- Avenzo Therapeutics Recruiting Site - Austin
- Avenzo Therapeutics Recruiting Site - Irving
Florida
- Avenzo Therapeutics Recruiting Site - Orlando
Massachusetts
- Avenzo Therapeutics Recruiting Site - Boston
South Carolina
- Avenzo Therapeutics Recruiting Site - Myrtle Beach
Tennessee
- Avenzo Therapeutics Recruiting Site - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2025-10-02 |
| Est. Completion | 2030-09 |
| Phase | Phase 1 |
What NCT07193511 shows while recruiting
NCT07193511 is an interventional study that assigns participants to a tested intervention. The registered 355 participants enrollment target is mid-sized for trials with a published cap, below the 560-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (37% lower).
The record links to 4 conditions, with Urothelial Cancer appearing as the primary indexed condition, and to 2 interventions - of which AVZO-103 is the first listed.
NCT07193511 lists 6 locations in 5 states (Texas, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT07193511 about?
NCT07193511 is a clinical study titled "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)". 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 o...
What is the current status of trial NCT07193511?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 355 participants. The study started on 2025-10-02. Estimated completion is 2030-09.
What conditions does trial NCT07193511 study?
This clinical trial studies the following conditions: Urothelial Cancer, Metastatic Solid Tumors, Solid Tumor Cancer, Locally Advanced.
What interventions are being tested in trial NCT07193511?
The interventions under investigation include: AVZO-103 (DRUG), Combination Agent (DRUG).
Who is sponsoring clinical trial NCT07193511?
This trial is sponsored by Avenzo Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07193511 being conducted?
This trial has 6 study locations across Florida, Massachusetts, South Carolina, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07193511's enrollment target sits among peer trials
355 13th of 25 higher than 13 of 25 other Urothelial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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