Study of AVZO-021 in Patients With Advanced Solid Tumors

September 23, 2026 updated by: Avenzo Therapeutics, Inc.

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

AVZO-021 is a compound being developed for the treatment of patients with advanced solid tumors, specifically, HR+/HER2- breast cancer and cyclin E1 (CCNE1) altered malignancies. AVZO-021 is a selective and potent cyclin-dependent kinase 2 (CDK2) inhibitor, which plays an important role in cell cycle regulation. This is a Phase 1/2 first-in-human, open-label, nonrandomized, multicenter study of AVZO-021. Phase 1 is a dose-escalation phase aimed at assessing the safety and tolerability of AVZO-021 and determining the recommended phase 2 dose (RP2D) as monotherapy and combination therapy. Phase 2 is a dose-expansion phase that will be conducted to assess the antitumor activity of AVZO-021 as monotherapy and combination therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
      • Wollongong, New South Wales, Australia
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
      • New York, New York, United States, 10016
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Avenzo Therapeutics Recruiting Site
        • Contact:
          • Avenzo Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. 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) breast cancer, who have been previously treated with inhibitor of CDK4/6 and endocrine therapy(Cohorts 1B1, 1B2, 1B3, 1B4, and 1B5); or histologically or cytologically confirmed diagnosis of CCNE1- amplified, locally advanced or metastatic, platinum-refractory or platinum-resistant EOC, primary peritoneal, or fallopian tube cancer (Cohort 1C).

    iii) Phase 2a Monotherapy dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic CCNE1 amplified 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 (Cohort 2A).

    iv) Phase 2b Combination dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+/HER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer who have been previously treated with no more than 1 prior CDK4/6 inhibitor and endocrine therapy (Cohorts 2B1, 2B2, 2B3, 2B4, and 2B5); or Histologically or cytologically confirmed diagnosis of locally advanced or metastatic, CCNE1-amplified, platinum-refractory or platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer (Cohort 2C).

  3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (excepting patients treated with an antibody-drug conjugate, with ovarian cancer if there disease is platinum resistant or refractory, having progressed beyond all SOC care; and patients who have received prior chemotherapy in the adjuvant or neoadjuvant setting >12 months prior to starting AVZO-021 treatment).

  4. Measurable disease as determined by RECIST version 1.1.

  5. Adequate bone marrow and organ function.

  6. Ability to swallow capsules or tablets.

Key Exclusion Criteria:

  1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.
  2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted.
  3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.
  4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.
  5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.
  6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade >1 at the time of starting study treatment.
  7. Clinically unstable cardiac function as described in the protocol.
  8. Any active or chronic infection/disease that compromises the immune system.
  9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.
  10. Active second malignancy unless in remission with life expectancy > 2 years and with documented sponsor approval.
  11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1, monotherapy (Part 1A)

Escalating doses of once daily, oral AVZO-021 in 28-day cycles.
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)
Experimental: Phase 1, combination (Parts 1B and 1C)

Escalating doses of once daily, oral AVZO-021 in 28-day cycles starting at least 1 DL below the monotherapy MTD/RP2D dose in combination with:

1B1) fulvestrant

1B2) palbociclib plus either fulvestrant or letrozole

1B3) ribociclib plus either fulvestrant or letrozole

1B4) abemaciclib plus either fulvestrant or letrozole

1B5) sacituzumab govitecan-hziy

1C) carboplatin
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

Other Names:
  • Ibrance
Drug: Fulvestrant

Antineoplastic agent, estrogen receptor antagonist

Other Names:
  • Faslodex
Drug: Letrozole

Antineoplastic agent, aromatase inhibitor

Other Names:
  • Femara
Drug: Ribociclib

Antineoplastic CDK4/6 inhibitor

Other Names:
  • Kisqali
Drug: Abemaciclib

Antineoplastic CDK4/6 inhibitor

Other Names:
  • Verzenio
Drug: Carboplatin

Alkylating agent

Drug: Sacituzumab Govitecan-hziy

Trop-2 antibody and topoisomerase inhibitor

Other Names:
  • Trodelvy
Experimental: Phase 2, monotherapy (Part 2A)

Oral doses of AVZO-021 in 28-day cycles at the RP2D determined in Part 1A.
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)
Experimental: Phase 2, combination (Parts 2B and 2C)

Oral doses of AVZO-021 in 28-day cycles at the RP2D determined in Parts 1B/1C, in combination with:

2B1) fulvestrant

2B2) palbociclib plus either fulvestrant or letrozole

2B3) ribociclib plus either fulvestrant or letrozole

2B4) abemaciclib plus either fulvestrant or letrozole

2B5) sacituzumab govitecan-hziy

2C) carboplatin
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

Other Names:
  • Ibrance
Drug: Fulvestrant

Antineoplastic agent, estrogen receptor antagonist

Other Names:
  • Faslodex
Drug: Letrozole

Antineoplastic agent, aromatase inhibitor

Other Names:
  • Femara
Drug: Ribociclib

Antineoplastic CDK4/6 inhibitor

Other Names:
  • Kisqali
Drug: Abemaciclib

Antineoplastic CDK4/6 inhibitor

Other Names:
  • Verzenio
Drug: Carboplatin

Alkylating agent

Drug: Sacituzumab Govitecan-hziy

Trop-2 antibody and topoisomerase inhibitor

Other Names:
  • Trodelvy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28 Days
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.
Approximately 22 months
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.
Approximately 16 months
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.
Approximately 52 months
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.
Approximately 52 months
Overall Survival (OS) (Phase 2)
Time Frame: Approximately 76 months

Defined as the time from study drug treatment initiation to death from any cause.
Approximately 76 months
Duration of response (DOR) (Phase 2)
Time Frame: Approximately 52 months

Defined as the time from the first confirmed response to radiologic/objective progression.
Approximately 52 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK Parameters: Maximum plasma concentration (Cmax) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Time to maximum plasma concentration (Tmax) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-last) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-tau) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Minimum observed plasma concentration at steady state (Cmin, ss) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Accumulation ration (Rac) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Elimination half-life (t1/2) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Apparent clearance (CL/F) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
PK Parameters: Apparent volume of distribution during terminal phase (Vz/F) (monotherapy and combination)
Time Frame: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days)
Evaluate the effect of a high-fat meal on the PK of AVZO-021 (Phase 1)
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avenzo Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVZO-021-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings