Study of AVZO-021 in Patients With Advanced Solid Tumors
NCT ID: NCT05867251
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
430 participants
INTERVENTIONAL
2023-08-30
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1, monotherapy (Part 1A)
Escalating doses of once daily, oral AVZO-021 in 28-day cycles.
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)
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
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)
Palbociclib
Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor
Fulvestrant
Antineoplastic agent, estrogen receptor antagonist
Letrozole
Antineoplastic agent, aromatase inhibitor
Ribociclib
Antineoplastic CDK4/6 inhibitor
Abemaciclib
Antineoplastic CDK4/6 inhibitor
Carboplatin
Alkylating agent
Sacituzumab Govitecan-hziy
Trop-2 antibody and topoisomerase inhibitor
Phase 2, monotherapy (Part 2A)
Oral doses of AVZO-021 in 28-day cycles at the RP2D determined in Part 1A.
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)
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
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)
Palbociclib
Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor
Fulvestrant
Antineoplastic agent, estrogen receptor antagonist
Letrozole
Antineoplastic agent, aromatase inhibitor
Ribociclib
Antineoplastic CDK4/6 inhibitor
Abemaciclib
Antineoplastic CDK4/6 inhibitor
Carboplatin
Alkylating agent
Sacituzumab Govitecan-hziy
Trop-2 antibody and topoisomerase inhibitor
Interventions
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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)
Palbociclib
Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor
Fulvestrant
Antineoplastic agent, estrogen receptor antagonist
Letrozole
Antineoplastic agent, aromatase inhibitor
Ribociclib
Antineoplastic CDK4/6 inhibitor
Abemaciclib
Antineoplastic CDK4/6 inhibitor
Carboplatin
Alkylating agent
Sacituzumab Govitecan-hziy
Trop-2 antibody and topoisomerase inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Avenzo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oklahoma University
Oklahoma City, Oklahoma, United States
Providence Cancer Institute
Portland, Oregon, United States
Sidney Kimmel Cancer Center (SKCC) at Jefferson Health
Philadelphia, Pennsylvania, United States
Texas Oncology - DFW
Dallas, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Macquarie University Hospital
Macquarie University, New South Wales, Australia
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Yale Cancer Center
Role: primary
Florida Cancer Specialists
Role: primary
Moffitt Cancer Center
Role: primary
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Role: primary
NYU Langone Medical Center (Tisch Hospital)
Role: primary
University Hospitals Cleveland Medical Center
Role: primary
Oklahoma University
Role: primary
Providence Cancer Institute
Role: primary
Sidney Kimmel Cancer Center (SKCC)
Role: primary
Texas Oncology - DFW
Role: primary
NEXT Virginia
Role: primary
Macquarie University Hospital
Role: primary
Cancer Care Wollongong
Role: primary
Other Identifiers
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AVZO-021-1001
Identifier Type: -
Identifier Source: org_study_id
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