NCT07038343

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Avenzo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-04
• Primary completion: 2030-06-01
• Completion: 2030-12-01
• First posted: 2025-06-26
• Last updated: 2026-02-20

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study