A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy \> 3 months
• Patients with histologically or cytologically proven advanced malignancies of preferred indications
• Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. Bone only disease is allowed in dose escalation.
• Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable
• Adequate renal, liver, and bone marrow function
Locations
United States
California
Avenzo Therapeutics Recruiting Site
RECRUITING
Los Angeles
Avenzo Therapeutics Recruiting Site
RECRUITING
Los Angeles
Connecticut
Avenzo Therapeutics Recruiting Site
RECRUITING
New Haven
Florida
Avenzo Therapeutics Recruiting Site
RECRUITING
Orlando
Avenzo Therapeutics Recruiting Site
RECRUITING
Sarasota
Avenzo Therapeutics Recruiting Site
RECRUITING
Tampa
Massachusetts
Avenzo Therapeutics Recruiting Site
RECRUITING
Boston
New York
Avenzo Therapeutics Recruiting Site
RECRUITING
New York
Ohio
Avenzo Therapeutics Recruiting Site
RECRUITING
Cleveland
Avenzo Therapeutics Recruiting Site
RECRUITING
Columbus
Tennessee
Avenzo Therapeutics Recruiting Site
RECRUITING
Nashville
Texas
Avenzo Therapeutics Recruiting Site
RECRUITING
Fort Worth
Avenzo Therapeutics Recruiting Site
RECRUITING
Houston
Avenzo Therapeutics Recruiting Site
RECRUITING
San Antonio
Virginia
Avenzo Therapeutics Recruiting Site
RECRUITING
Fairfax
Washington
Avenzo Therapeutics Recruiting Site
RECRUITING
Seattle
Contact Information
Primary
Medical Information
ClinicalTrials@avenzotx.com
(858) 239-2944
Time Frame
Start Date:2025-08-20
Estimated Completion Date:2030-08
Participants
Target number of participants:380
Treatments
Experimental: Phase 1, monotherapy (Part 1A) and food effect
Escalating doses of twice daily, oral AVZO-023 in 28-day cycles, with addition of fulvestrant
Experimental: Phase 1, combination (Parts 1B)
Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021 in 28-day cycles, with addition of fulvestrant
Experimental: Phase 1, combination (Parts 1C)
Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021, with once daily, oral letrozole in 28-day cycles
Experimental: Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D)
Oral doses of AVZO-023 in 28-day cycles at the RP2D determined in Part 1B/1C, in combination with:~2A) letrozole~2B) fulvestrant~2C) AVZO-021 plus fulvestrant~2D) AVZO-021 plus letrozole