AVZO-023 for Advanced Breast Cancer

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

Recruiting Phase 1 Phase 2 Interventional Study
HR+/HER2- Breast Cancer HR+, HER2-, Advanced Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
380 (estimated)
Sponsor
Avenzo Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with advanced breast cancer to test a new oral medication called AVZO-023. Participants will help researchers understand how safe and effective this treatment is.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have advanced breast cancer confirmed by a doctor.
  • I have measurable disease.
  • I can provide test results and tumors samples.
  • I have good kidney, liver, and bone marrow function.
  • I have a life expectancy of more than 3 months.

You may not be able to join if

  • I have received investigational CDK inhibitors before.
  • I have active brain metastasis or leptomeningeal disease.
  • I have another invasive cancer or had one treated in the last 3 years.
  • My last cancer treatment was within 2 weeks.
  • I had major surgery in the last 4 weeks.
  • I received radiotherapy for palliative care within 7 days.
  • I have serious heart problems in the last 6 months.
  • I have unresolved serious side effects from previous treatments.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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).

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy \> 3 months * Patients with histologically or cytologically proven advanced malignancies of preferred indications * Measurable disease (as assessed by inv…
Contacts

Medical Information

(858) 239-2944

ClinicalTrials@avenzotx.com

CONTACT