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HR+, HER2 , Advanced Breast Cancer / Letrozole / AVZO-021 · Phase 1/2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a first-in-human trial registration for AVZO-023, a CDK4 inhibitor, in advanced solid tumors including HR+/HER2- breast cancer. The study is actively recruiting and aims to establish safety, tolerability, maximum tolerated dose, and preliminary anti-tumor activity. No efficacy or safety results are yet posted in this registry record.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer; age from 18 Years. Intervention: Phase 1, monotherapy (Part 1A) and food effect; Phase 1, combination (Parts 1B); Phase 1, combination (Parts 1C); Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D). n = 380. 16 sites: United States.
This is a first-in-human trial registration for AVZO-023, a CDK4 inhibitor, in advanced solid tumors including HR+/HER2- breast cancer. The study is actively recruiting and aims to establish safety, tolerability, maximum tolerated dose, and preliminary anti-tumor activity. No efficacy or safety results are yet posted in this registry record.
No efficacy or safety results have been posted in this registry record; this is a planned study only. Duration of follow-up and long-term safety data are not yet available.
This is a trial registration with no reported results; clinicians should not draw any conclusions about safety or efficacy at this stage. Enrollment is ongoing and results will require publication in peer-reviewed literature before clinical application.
This is a Phase 1/2 first-in-human trial registration with no results posted; it describes planned safety, tolerability, and dose-finding work in a new CDK4 inhibitor.
As stated by the source record.
Quoted from the source exactly as published.
This is a trial registration with no reported results; clinicians should not draw any conclusions about safety or efficacy at this stage. Enrollment is ongoing and results will require publication in peer-reviewed literature before clinical application.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06998407). This is a study registration, not published results. Lead sponsor: Avenzo Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 380 participants (ESTIMATED). Conditions: HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer. Interventions: DRUG: AVZO-021; DRUG: Fulvestrant; DRUG: Letrozole; DRUG: AVZO-023. Primary outcome measures: Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) , Cycle 1 (28 Days); Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) , From baseline until end of study treatment or study completion (approximately 2 years); Determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) (Phase 1) , Approximately 16 months; Objective Response Rate (ORR) (Phase 2) , From baseline through disease progression or study completion (approximately 2 years). Brief summary: 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.