NCT05867251 · Avenzo Therapeutics, Inc.
Study of AVZO-021 in Patients With Advanced Solid Tumors
What this study is about
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, how the drug moves through the body, how the drug affects the body, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an taken by mouth medication that inhibits cyclin-dependent kinase 2 (CDK 2).
View original scientific description
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).
Interventions
DRUG
AVZO-021
AVZO-021 is a selective and potent oral inhibitor of CDK2 being developed for the treatment of patients with advanced solid tumors with CDK2 dependency (1A), CCNE1 amplified solid tumors (2A), HR+/HER2- BC (1B1-1B5, 2B1-2B5) and CCNE1 amplified EOC (1C, 2C)
DRUG
Palbociclib
Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor
DRUG
Fulvestrant
Antineoplastic agent, estrogen receptor antagonist
DRUG
Letrozole
Antineoplastic agent, aromatase inhibitor
DRUG
Ribociclib
Antineoplastic CDK4/6 inhibitor
DRUG
Abemaciclib
Antineoplastic CDK4/6 inhibitor
DRUG
Carboplatin
Alkylating agent
DRUG
Sacituzumab Govitecan-hziy
Trop-2 antibody and topoisomerase inhibitor
Primary outcome measures
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Time frame: 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: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Approximately 76 months
Defined as the time from study drug treatment initiation to death from any cause.
Duration of response (DOR) (Phase 2)
Time frame: Approximately 52 months
Defined as the time from the first confirmed response to radiologic/objective progression.
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. 2. Disease-related inclusion criteria by study phase and part: i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+/HER2- breast cancer, CCNE1-amplified tumors that are either epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor. Patients with any additional tumor type with CCNE1 amplification can be enrolled only if clinical data is supportive and approved by medical monitor (Cohort 1A). ii) Phase 1b Combination Dose Escalation: histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+ HER2- (HER2-low may be allowed if failed standard of care therapy) b
Where
- New Haven, Connecticut
- Sarasota, Florida
- Tampa, Florida
- Mineola, New York
- New York, New York
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Portland, Oregon
- Philadelphia, Pennsylvania
- Dallas, Texas
- Fairfax, Virginia
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 Nov 19, 2025 · Source of record for eligibility and locations