Study of AVZO-021 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).
| Condition(s) | Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification, Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Endometrial Cancer, |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Avenzo Therapeutics, Inc. |
| Locations | New Haven, Connecticut, United States; Sarasota, Florida, United States; Tampa, Florida, United States; Mineola, New York, United States; New York, New York, United States; Cleveland, Ohio, United States (+7 more sites) |
| Start date | 2023-08-30 |
| NCT ID | NCT05867251 |
| Official listing | https://clinicaltrials.gov/study/NCT05867251 |