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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT05867251). This is a study registration, not published results. Lead sponsor: Avenzo Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 430 participants (ESTIMATED). Conditions: 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, TNBC - Triple-Negative Breast Cancer. Interventions: DRUG: AVZO-021; DRUG: Palbociclib; DRUG: Fulvestrant; DRUG: Letrozole; DRUG: Ribociclib; DRUG: Abemaciclib; DRUG: Carboplatin; DRUG: Sacituzumab Govitecan-hziy. Primary outcome measures: Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) , 28 Days; Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) , Approximately 22 months; Determination of Recommended Phase 2 Dose (RP2D) (Phase 1) , Approximately 16 months; Objective Response Rate (ORR) (Phase 2) , Approximately 52 months; Progression Free Survival (PFS) (Phase 2) , Approximately 52 months; Overall Survival (OS) (Phase 2) , Approximately 76 months; Duration of response (DOR) (Phase 2) , Approximately 52 months. Brief 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).