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)
Start Date
6/4/2025
Completion Date
12/1/2030
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
AVZO-1418
Combination Agent 1
Combination Agent 2
Conditions
Locations
Avenzo Therapeutics Recruiting Site
Gilbert, Arizona 85234
United States
Avenzo Therapeutics Recruiting Site
Los Angeles, California 90048
United States
Avenzo Therapeutics Recruiting Site
Denver, Colorado 80218
United States
Avenzo Therapeutics Recruiting Site
New Haven, Connecticut 06510
United States
Avenzo Therapeutics Recruiting Site
Washington D.C., District of Columbia 20007
United States
Avenzo Therapeutics Recruiting Site
Orlando, Florida 32827
United States
Avenzo Therapeutics Recruiting Site
Sarasota, Florida 34232
United States
Avenzo Therapeutics Recruiting Site
Tampa, Florida 33612
United States
Avenzo Therapeutics Recruiting Site
Atlanta, Georgia 30322
United States
Avenzo Therapeutics Recruiting Site
Boston, Massachusetts 02215
United States
Avenzo Therapeutics Recruiting Site
New York, New York 10029
United States
Avenzo Therapeutics Recruiting Site
Philadelphia, Pennsylvania 19107
United States
Avenzo Therapeutics Recruiting Site
Dallas, Texas 75039
United States
Avenzo Therapeutics Recruiting Site
Houston, Texas 77054
United States
Avenzo Therapeutics Recruiting Site
San Antonio, Texas 78229
United States
Avenzo Therapeutics Recruiting Site
West Valley City, Utah 84119
United States
Avenzo Therapeutics Recruiting Site
Fairfax, Virginia 22031
United States
Avenzo Therapeutics Recruiting Site
Seattle, Washington 98109
United States