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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)

RecruitingPhase 1/2

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Avenzo Therapeutics, Inc. · Participants: 480 · Started: Jun 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07038343

Locations in the U.S.

ArizonaAvenzo Therapeutics Recruiting Site, Gilbert
CaliforniaAvenzo Therapeutics Recruiting Site, Los Angeles
Avenzo Therapeutics Recruiting Site, Los Angeles
ColoradoAvenzo Therapeutics Recruiting Site, Denver
ConnecticutAvenzo Therapeutics Recruiting Site, New Haven
District of ColumbiaAvenzo Therapeutics Recruiting Site, Washington D.C.
FloridaAvenzo Therapeutics Recruiting Site, Orlando
Avenzo Therapeutics Recruiting Site, Sarasota
Avenzo Therapeutics Recruiting Site, Tampa
GeorgiaAvenzo Therapeutics Recruiting Site, Atlanta
MassachusettsAvenzo Therapeutics Recruiting Site, Boston
New YorkAvenzo Therapeutics Recruiting Site, New York
PennsylvaniaAvenzo Therapeutics Recruiting Site, Philadelphia
TexasAvenzo Therapeutics Recruiting Site, Dallas
Avenzo Therapeutics Recruiting Site, Houston
Avenzo Therapeutics Recruiting Site, San Antonio
UtahAvenzo Therapeutics Recruiting Site, West Valley City
VirginiaAvenzo Therapeutics Recruiting Site, Fairfax
WashingtonAvenzo Therapeutics Recruiting Site, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.