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NCT07038343PHASE1, PHASE2Recruiting

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)

Avenzo Therapeutics, Inc.

Start Date

6/4/2025

Completion Date

12/1/2030

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.

Detailed Description

This first-in-human, Phase 1/2 study will aim to obtain safety and tolerability data when AVZO-1418 is administered intravenously to patients with locally advanced or metastatic epithelial solid tumors. Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-1418 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-1418 as a monotherapy. This data can guide selection of combination schedules and agents. Phase 2 is a dose expansion phase that will aim to assess the antitumor activity of AVZO-1418 as a monotherapy and potentially in combination therapy.

Eligibility Criteria

Age Range: 18 years to 75 years

Key Inclusion Criteria * Patient must be an adult, between 18 and 75 years of age 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: o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol). * 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. * Other protocol-defined Inclusion criteria apply. Key Exclusion Criteria * Uncontrolled hypertension. * 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. * 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 a solid organ transplant. * Other protocol-defined Exclusion criteria apply.

Interventions

DRUG

AVZO-1418

DRUG

Combination Agent 1

DRUG

Combination Agent 2

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Conditions

Solid Tumor CancerLocally AdvancedMetastatic Solid TumorsLung CancersEpithelial TumorBiliary Tract Cancer (BTC)Urothelial CancerNasopharyngeal Cancers

Locations

Avenzo Therapeutics Recruiting Site

Gilbert, Arizona 85234

United States

Avenzo Therapeutics Recruiting Site

Los Angeles, California 90048

United States

Avenzo Therapeutics Recruiting Site

Denver, Colorado 80218

United States

Avenzo Therapeutics Recruiting Site

New Haven, Connecticut 06510

United States

Avenzo Therapeutics Recruiting Site

Washington D.C., District of Columbia 20007

United States

Avenzo Therapeutics Recruiting Site

Orlando, Florida 32827

United States

Avenzo Therapeutics Recruiting Site

Sarasota, Florida 34232

United States

Avenzo Therapeutics Recruiting Site

Tampa, Florida 33612

United States

Avenzo Therapeutics Recruiting Site

Atlanta, Georgia 30322

United States

Avenzo Therapeutics Recruiting Site

Boston, Massachusetts 02215

United States

Avenzo Therapeutics Recruiting Site

New York, New York 10029

United States

Avenzo Therapeutics Recruiting Site

Philadelphia, Pennsylvania 19107

United States

Avenzo Therapeutics Recruiting Site

Dallas, Texas 75039

United States

Avenzo Therapeutics Recruiting Site

Houston, Texas 77054

United States

Avenzo Therapeutics Recruiting Site

San Antonio, Texas 78229

United States

Avenzo Therapeutics Recruiting Site

West Valley City, Utah 84119

United States

Avenzo Therapeutics Recruiting Site

Fairfax, Virginia 22031

United States

Avenzo Therapeutics Recruiting Site

Seattle, Washington 98109

United States