Status and phase
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About
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).
Full 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.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.
Disease-related inclusion criteria by study phase and part:
i) Phase 1a Monotherapy Dose Escalation: Locally advanced or metastatic solid tumor associated with dependency on CDK2 (eg, HR+/HER2- breast cancer, CCNE1 amplified solid tumors, FBXW7 loss of function mutation/deletion and retinoblastoma protein (Rb)1 loss of function mutation/deletion), for which standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator (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 in patients who have been previously treated with inhibitor of CDK4/6 and endocrine therapy (Cohorts 1B1, 1B2, 1B3, and 1B4); or Histologically or cytologically confirmed diagnosis of CCNE1 amplified locally advanced or metastatic EOC in patients who are platinum-refractory or platinum-resistant (Cohort 1C).
iii) Phase 2a Monotherapy dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic CCNE1 amplified solid tumors 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, and 2B4); or Histologically or cytologically confirmed diagnosis of CCNE1 amplified locally advanced or metastatic EOC in patients who are platinum-refractory or platinum-resistant (Cohort 2C).
No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (prior chemotherapy in the adjuvant or neoadjuvant setting allowed if >12 months prior to starting AVZO-021 treatment and is not considered a prior line).
Measurable disease as determined by RECIST version 1.1.
Adequate bone marrow and organ function.
Ability to swallow capsules or tablets.
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
430 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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