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)

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT07038343
Trial Phases:	Phase I Phase II	Protocol IDs:	AVZO-1418-1001 (primary) NCI-2025-07534
Eligibility:	18 - 75 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Avenzo Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT07038343

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.