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
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Avenzo Therapeutics Recruiting Site
RECRUITING
Denver
Florida
Avenzo Therapeutics Recruiting Site
RECRUITING
Orlando
Avenzo Therapeutics Recruiting Site
RECRUITING
Sarasota
Texas
Avenzo Therapeutics Recruiting Site
RECRUITING
Dallas
Avenzo Therapeutics Recruiting Site
RECRUITING
Houston
Avenzo Therapeutics Recruiting Site
RECRUITING
San Antonio
Utah
Avenzo Therapeutics Recruiting Site
RECRUITING
West Valley City
Virginia
Avenzo Therapeutics Recruiting Site
RECRUITING
Fairfax
Contact Information
Primary
Medical Information
ClinicalTrials@avenzotx.com
(858) 239-2944
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2030-12
Participants
Target number of participants: 430
Treatments
Experimental: Phase 1, monotherapy
Group A
Experimental: Phase 1, combination
Group B
Experimental: Phase 2, monotherapy
Part A
Experimental: Phase 2, combination
Part B
Related Therapeutic Areas
Sponsors
Leads: Avenzo Therapeutics, Inc.

This content was sourced from clinicaltrials.gov