Actively Recruiting
Study of AVZO-021 in Patients With Advanced Solid Tumors
Led by Avenzo Therapeutics, Inc. · Updated on 2025-11-19
430
Participants Needed
13
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).
CONDITIONS
Official Title
Study of AVZO-021 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older with ECOG performance status 0-1
- Diagnosis by study phase and cohort of advanced HR+/HER2- breast cancer, CCNE1-amplified tumors including epithelial ovarian, primary peritoneal, fallopian tube, endometrial cancers or triple-negative breast cancer
- No more than 2 prior cytotoxic chemotherapy regimens for advanced disease (exceptions apply)
- Measurable disease by RECIST version 1.1 criteria
- Adequate bone marrow and organ function
- Ability to swallow capsules or tablets
You will not qualify if you...
- Received investigational or anticancer therapy within 2 weeks or 5 half-lives before starting AVZO-021
- Prior treatment with CDK2 inhibitors, PKMYT1 inhibitors, or WEE1 inhibitors; for specific cohort, no prior topoisomerase inhibitor therapy
- Major surgery within 4 weeks before starting AVZO-021
- Radiotherapy for palliation within 7 days before first study dose unless specified
- Active central nervous system metastases or leptomeningeal disease
- Unresolved toxicities from prior therapy greater than CTCAE grade 1
- Clinically unstable cardiac function
- Active or chronic infections or immune compromising diseases
- Current treatment with strong/moderate CYP3A4 inhibitors or inducers
- Active second malignancy unless in remission with life expectancy over 2 years and sponsor approval
- Pregnancy, breastfeeding, or plans to breastfeed during the study or within 6 months after last dose
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
5
NYU Langone Medical Center (Tisch Hospital)
New York, New York, United States, 10016
Actively Recruiting
6
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
7
Oklahoma University
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
8
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
9
Sidney Kimmel Cancer Center (SKCC) at Jefferson Health
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
11
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
12
Macquarie University Hospital
Macquarie University, New South Wales, Australia
Actively Recruiting
13
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Actively Recruiting
Research Team
M
Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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