RecruitingPhase 1Phase 2NCT07038343

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 1/2, 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

Sponsor

Avenzo Therapeutics, Inc.

Enrollment

430 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancers Locally Advanced Solid Tumor Cancer Metastatic Solid Tumors Epithelial Tumor

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study (AVENTINE-1) tests a new drug called AVZO-1418, alone and in combination with other cancer treatments, in adults with advanced or metastatic solid tumors that have not responded to available therapies. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed advanced or metastatic solid tumor cancer - Your general health is good enough to participate (ECOG performance status of 0 or 1) - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You have certain specific cancer types excluded from the study - You have active brain metastases or serious autoimmune conditions - You have had recent major surgery or unresolved treatment-related side effects Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAVZO-1418

Specific dose in protocol specified schedule

DRUGCombination Agent 1

Per label based on combination agent used

DRUGCombination Agent 2

Per label based on combination agent used