NCT06998407 · Avenzo Therapeutics, Inc.
Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors
What this study is about
This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, how the drug moves through the body (PK), how the drug affects the body, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an taken by mouth medication that inhibits cyclin-dependent kinase 4 (CDK4).
View original scientific description
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).
Interventions
DRUG
AVZO-021
AVZO-021 is an oral selective CDK2 inhibitor
DRUG
Fulvestrant
Antineoplastic agent, estrogen receptor antagonist
DRUG
Letrozole
Antineoplastic agent, aromatase inhibitor
DRUG
AVZO-023
AVZO-023 is an oral selective CDK4 inhibitor
Primary outcome measures
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Time frame: Cycle 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)
Time frame: From baseline until end of study treatment or study completion (approximately 2 years)
Determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) (Phase 1)
Time frame: Approximately 16 months
Objective Response Rate (ORR) (Phase 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. For patients with HR+/HER2- breast cancer enrolled in dose escalation, bone only disease is allowed
- 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 Key
Exclusion criteria
- Patients should not have received prior selective CDK (CDK2, CDK4, CDK2/4, CDK2/4/6) inhibitors
- Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervo
Where
- Los Angeles, California
- New Haven, Connecticut
- Orlando, Florida
- Sarasota, Florida
- Boston, Massachusetts
- New York, New York
- Cleveland, Ohio
- Columbus, Ohio
- Nashville, Tennessee
- Fort Worth, Texas
- Houston, Texas
- San Antonio, Texas
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations