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Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors
Trial Status: active
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).
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 nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease
Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps
Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
Major surgery within 4 weeks prior to first dose on study
Have received radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have active radiation pneumonitis
Strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
History of serious cardiovascular conditions within 6 months prior to first dose on study
Unresolved toxicities from prior therapy greater than Grade 1 (per CTCAE version 5.0) (with exceptions of alopecia, vitiligo, and ≤ Grade 2 peripheral neuropathy) prior to the first dose on study
History of drug-induced pneumonitis/interstitial lung disease
Additional locations may be listed on ClinicalTrials.gov for NCT06998407.
