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

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

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

Led by Avenzo Therapeutics, Inc. · Updated on 2026-05-04

380

Participants Needed

Research Sites

258 weeks

Total Duration

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 18 years or older with ECOG performance status 0-1 and life expectancy greater than 3 months
Histologically or cytologically confirmed advanced malignancies of preferred indications
Measurable disease preferred in Phase 1 dose escalation and required in Phase 2; bone only disease allowed in dose escalation
Agree to provide molecular test results and tumor samples or fresh biopsy as applicable
Adequate kidney, liver, and bone marrow function

You will not qualify if you...

Prior treatment with selective investigational CDK inhibitors (CDK2, CDK4, CDK2/4, CDK2/4/6)
Known active brain metastasis or leptomeningeal disease
Other invasive malignancies or prior invasive malignancy treated within 3 years, except certain skin cancers or colorectal polyps
Anticancer treatment within 2 weeks (4 weeks for biologics/immunotherapy/ADC) or 5 half-lives of the drug prior to first study dose
Major surgery within 4 weeks prior to first study dose
Radiotherapy with limited field within 7 days prior to first study dose, except whole brain radiotherapy completed at least 4 weeks prior
Use of strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives prior to first study dose
Serious cardiovascular conditions within 6 months prior to first study dose
Unresolved toxicities greater than Grade 1 from prior therapy (except alopecia, vitiligo, and up to Grade 2 peripheral neuropathy)
History of drug-induced pneumonitis or interstitial lung disease
Confirmed loss of function mutation or deletion of Rb1 gene

AI-Screening