drugset / Trial / NCT06998407

ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors

NCT06998407

Phase 1/2 Recruiting 380 enrolled Avenzo Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2025-08-20
Primary completion
2028-08
Completion
2030-08

Drugs

EvaluationDrugModalityDoseRoute
Subject AVZO-021 Unknown Oral
Subject AVZO-023 Unknown Oral
Subject Fulvestrant Small molecule
Subject Letrozole Other / unclassified Oral