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)
NCT07038343 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2026-05-13
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.
Conditions
- Solid Tumor Cancer
- Locally Advanced
- Metastatic Solid Tumors
- Lung Cancers
- Epithelial Tumor
- Biliary Tract Cancer (BTC)
- Urothelial Cancer
- Nasopharyngeal Cancers
Interventions
- DRUG
-
AVZO-1418
Specific dose in protocol specified schedule
- DRUG
-
Combination Agent 1
Per label based on combination agent used
- DRUG
-
Combination Agent 2
Per label based on combination agent used
Sponsors & Collaborators
-
Avenzo Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-04
- Primary Completion
- 2030-06-30
- Completion
- 2030-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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