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NCT07038343 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Metastatic Solid Tumors and Solid Tumor Cancer, sponsored by Avenzo Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 430
- Enrollment target
- 16
- Study locations
NCT07038343: Recruiting Phase 1 study of Metastatic Solid Tumors and Solid Tumor Cancer, sponsored by Avenzo Therapeutics.
NCT07038343 is a Phase 1 study of Metastatic Solid Tumors and Solid Tumor Cancer that is actively recruiting participants, run by Avenzo Therapeutics. The registered enrollment target is 430 participants, above the 185-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (132% higher). The trial reports 16 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07038343, a Phase 1 study of Metastatic Solid Tumors and Solid Tumor Cancer, is actively recruiting participants, sponsored by Avenzo Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 430 participants
- Enrollment target
- 16
- Study locations
Study Summary
This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial 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-1418
- DRUG Combination Agent 1
- DRUG Combination Agent 2
Study Locations (16)
Texas
- Avenzo Therapeutics Recruiting Site - Dallas
- Avenzo Therapeutics Recruiting Site - Houston
- Avenzo Therapeutics Recruiting Site - San Antonio
Florida
- Avenzo Therapeutics Recruiting Site - Orlando
- Avenzo Therapeutics Recruiting Site - Sarasota
Arizona
- Avenzo Therapeutics Recruiting Site - Gilbert
California
- Avenzo Therapeutics Recruiting Site - Los Angeles
Colorado
- Avenzo Therapeutics Recruiting Site - Denver
Connecticut
- Avenzo Therapeutics Recruiting Site - New Haven
District of Columbia
- Avenzo Therapeutics Recruiting Site - Washington D.C.
Georgia
- Avenzo Therapeutics Recruiting Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2025-06-04 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
What NCT07038343 shows while recruiting
NCT07038343 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, above the 185-participant average among 20 other Metastatic Solid Tumors trials with a reported enrollment target (132% higher).
The record links to 5 conditions, with Metastatic Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which AVZO-1418 is the first listed.
NCT07038343 lists 16 locations in 13 states (Texas, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT07038343 about?
NCT07038343 is a clinical study titled "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)". This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with loca...
What is the current status of trial NCT07038343?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 430 participants. The study started on 2025-06-04. Estimated completion is 2030-12.
What conditions does trial NCT07038343 study?
This clinical trial studies the following conditions: Metastatic Solid Tumors, Solid Tumor Cancer, Locally Advanced, Lung Cancers, Epithelial Tumor.
What interventions are being tested in trial NCT07038343?
The interventions under investigation include: AVZO-1418 (DRUG), Combination Agent 1 (DRUG), Combination Agent 2 (DRUG).
Who is sponsoring clinical trial NCT07038343?
This trial is sponsored by Avenzo Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07038343 being conducted?
This trial has 16 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07038343's enrollment target sits among peer trials
430 3rd of 20 higher than 18 of 20 other Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
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