RecruitingPhase 1 / Phase 2NCT07038343
Official study title

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)

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAVZO-1418 and Combination Agent 1

Plus 1 other study approaches.

Who it may be forLocally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?27 U.S. locations

Locations may change over time.

Who runs it?Avenzo Therapeutics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Avenzo Therapeutics, Inc.
Interventions being studied
Drug: AVZO-1418; Drug: Combination Agent 1; Drug: Combination Agent 2
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Avenzo Therapeutics Recruiting SiteGilbert, Arizona
  • Avenzo Therapeutics Recruiting SiteLos Angeles, California
  • Avenzo Therapeutics Recruiting SiteLos Angeles, California
  • Avenzo Therapeutics Recruiting SiteDenver, Colorado
  • Avenzo Therapeutics Recruiting SiteNew Haven, Connecticut
  • Avenzo Therapeutics Recruiting SiteWashington D.C., District of Columbia
  • Avenzo Therapeutics Recruiting SiteOrlando, Florida
  • Avenzo Therapeutics Recruiting SiteSarasota, Florida
  • Avenzo Therapeutics Recruiting SiteTampa, Florida
  • Avenzo Therapeutics Recruiting SiteAtlanta, Georgia
  • Avenzo Therapeutics Recruiting SiteBoston, Massachusetts
  • Avenzo Therapeutics Recruiting SiteNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 16, 2026. Always confirm current availability with the study team.

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