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).

Trial Details

NCT ID
NCT05867251
Phase
PHASE1 / PHASE2
Sponsor
Avenzo Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • AVZO-021
  • Palbociclib
  • Fulvestrant
  • Letrozole
  • Ribociclib
  • Abemaciclib
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Tampa, Florida, United States|27.94752,-82.45843
  • Mineola, New York, United States|40.74927,-73.64068
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility 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: Patients with locally advanced or metastatic HR+/HER2- breast cancer, CCNE1-amplified tumors that are eith…
  • ii) Phase 1b Combination Dose Escalation: histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+ HER2- (HER2-low…

For full eligibility, visit ClinicalTrials.gov.

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