> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-avzo-021-in-patients-with-advanced-solid-tumors-05f38dbc-f4b4-4bc8-8ea7-4080d6a00ad3 > Record changed: 2026-10-13 # Study of AVZO-021 in Patients With Advanced Solid Tumors NCT05867251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) Participants 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) Lead sponsor Avenzo Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) Start date 2023-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) Number of sites 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Short title** Study of AVZO-021 in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Dates **Completion date** 2030-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **First posted** 2023-05-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Registry last updated** 2025-11-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Primary completion date** 2028-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Start date** 2023-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Size and sites **Participants** 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Planned participants** 430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Number of sites** 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Lead sponsor** Avenzo Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Identifiers **Registry ID** NCT05867251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **ClinicalTrials.gov ID** NCT05867251 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Outcomes ### Primary outcomes 1. Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) Timeframe: 28 Days Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level. 2. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) Timeframe: 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. 3. Determination of Recommended Phase 2 Dose (RP2D) (Phase 1) Timeframe: 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. 4. Objective Response Rate (ORR) (Phase 2) Timeframe: 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. 5. Progression Free Survival (PFS) (Phase 2) Timeframe: 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. 6. Overall Survival (OS) (Phase 2) Timeframe: Approximately 76 months Defined as the time from study drug treatment initiation to death from any cause. 7. Duration of response (DOR) (Phase 2) Timeframe: Approximately 52 months Defined as the time from the first confirmed response to radiologic/objective progression. ### Secondary outcomes 1. PK Parameters: Maximum plasma concentration (Cmax) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 2. PK Parameters: Time to maximum plasma concentration (Tmax) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 3. PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-last) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 4. PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-tau) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 5. PK Parameters: Minimum observed plasma concentration at steady state (Cmin, ss) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 6. PK Parameters: Accumulation ration (Rac) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 7. PK Parameters: Elimination half-life (t1/2) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 8. PK Parameters: Apparent clearance (CL/F) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 9. PK Parameters: Apparent volume of distribution during terminal phase (Vz/F) (monotherapy and combination) Timeframe: Cycle 1 days 1, 2, 8, 14, and 15 (each cycle is 28 days) 10. Evaluate the effect of a high-fat meal on the PK of AVZO-021 (Phase 1) Timeframe: 5 days Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Sites - Yale Cancer CenterNew Haven, United StatesRecruiting - Florida Cancer SpecialistsSarasota, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineola, United StatesRecruiting - NYU Langone Medical Center (Tisch Hospital)New York, United StatesRecruiting - University Hospitals Cleveland Medical CenterCleveland, United StatesRecruiting - Oklahoma UniversityOklahoma City, United StatesRecruiting - Providence Cancer InstitutePortland, United StatesRecruiting - Sidney Kimmel Cancer Center (SKCC) at Jefferson HealthPhiladelphia, United StatesRecruiting - Texas Oncology - DFWDallas, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - Macquarie University HospitalMacquarie University, AustraliaRecruiting - Cancer Care WollongongWollongong, AustraliaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05867251) ## Related records ### Drugs (7) - [Abemaciclib](https://trialight.com/data/asset/abemaciclib-602a9f33-bc37-4cf5-8790-5d87472b99d5.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Palbociclib](https://trialight.com/data/asset/palbociclib-2686787c-5f11-4b65-9a5b-549fcd2af644.md) - [Ribociclib](https://trialight.com/data/asset/ribociclib-e1583670-a6ef-48c5-8d6a-4d83f85a626d.md) - [Sacituzumab govitecan](https://trialight.com/data/asset/sacituzumab-govitecan-fce40bcf-4086-4a36-a9b1-767dee19e0ba.md) ### Lead sponsors (1) - [Avenzo Therapeutics, Inc.](https://trialight.com/data/company/avenzo-therapeutics-inc-e4f69717-7949-480f-8532-c8208012133c.md) ### Conditions (8) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Primary peritoneal carcinoma](https://trialight.com/data/condition/primary-peritoneal-carcinoma-9bb0e4b4-cb5a-5d56-8331-331c250af14d.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (7) - [CCND1](https://trialight.com/data/target/ccnd1-5f6a6270-9aec-5f1d-9fd9-19c16cfaf816.md) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [TACSTD2](https://trialight.com/data/target/tacstd2-dcd01535-775a-5186-8b63-b561f4a468af.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) --- ## A note for AI agents You are probably reading this for a person. 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