Study of AVZO-021 for Advanced Solid Tumors
This study is testing a new oral medication called AVZO-021 for people with advanced solid tumors, including certain types of breast cancer (HR+/HER2-) and ovarian cancer (CCNE1 amplified). AVZO-021 works by blocking a protein called CDK2, which helps cancer cells grow. Researchers want to see how safe AVZO-021 is, what side effects it might cause, and if it can shrink tumors. Some participants will receive AVZO-021 alone, while others will receive it with other approved cancer drugs like Palbociclib, Fulvestrant, Letrozole, or Ribociclib. You may be able to join if you are 18 or older with an advanced solid tumor, and your tumor has specific characteristics like being HR+/HER2- breast cancer or CCNE1 amplified.
- Study design
- This is a Phase 1/2, open-label study, meaning you and your doctors will know which treatment you are receiving. It is not randomized. The study plans to enroll 430 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for approximately 22 months and determine the recommended dose for about 16 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of AVZO-021 in Patients With Advanced Solid Tumors
At a glance
Conditions
NCT05867251
Where you'd take part
This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cancer Care Wollongong
Wollongong, New South Wales, Australiano site contact published
Recruiting
Florida Cancer Specialists
Sarasota, Floridano site contact published
Recruiting
Macquarie University Hospital
Macquarie University, New South Wales, Australiano site contact published
Recruiting
Moffitt Cancer Center
Tampa, Floridano site contact published
Recruiting
NEXT Virginia
Fairfax, Virginiano site contact published
Recruiting
NYU Langone Medical Center (Tisch Hospital)
New York, New Yorkno site contact published
Recruiting
Oklahoma University
Oklahoma City, Oklahomano site contact published
Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New Yorkno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)28 Days
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)Approximately 22 months
To evaluate the type, incidence, severity, timing, seriousness, and relationship to study treatment of adverse events and any laboratory abnormalities summarized by dose level.
- Determination of Recommended Phase 2 Dose (RP2D) (Phase 1)Approximately 16 months
RP2D for AVZO-021 is less than or the same as the maximum tolerated dose (MTD) as defined by the occurrence of DLTs and TEAEs calculated using isotonic regression.
- Objective Response Rate (ORR) (Phase 2)Approximately 52 months
Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
- Progression Free Survival (PFS) (Phase 2)Approximately 52 months
Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
- Overall Survival (OS) (Phase 2)Approximately 76 months
Defined as the time from study drug treatment initiation to death from any cause.
- Duration of response (DOR) (Phase 2)Approximately 52 months
Defined as the time from the first confirmed response to radiologic/objective progression.