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ORION-1: Study of AVZO-023 for Advanced Solid Tumors

This study is looking at a new oral medication called AVZO-023, which works by targeting a protein called CDK4. It aims to find out how safe AVZO-023 is, what side effects it might cause, and how well it works against advanced solid tumors. Specifically, it will be tested alone and in combination with another drug, AVZO-021, and/or standard hormone therapy (like Fulvestrant or Letrozole) for people with HR+/HER2- breast cancer. To join, you must be at least 18 years old, have a good general health status (ECOG 0-1), and have advanced cancer that can be measured. The study will first determine the best dose of AVZO-023 and then look at its anti-tumor effects. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 380 participants. It will first assess safety and tolerability (Phase 1) and then anti-tumor activity (Phase 2).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events and lab abnormalities from baseline until the end of study treatment or study completion, which is approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Avenzo Therapeutics, Inc.
~380 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:AVZO-021FulvestrantLetrozoleAVZO-023

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Measured over Cycle 1 (28 Days)
+3 more outcomes measured

Conditions

HR+/HER2- Breast Cancer
HR+, HER2-, Advanced Breast Cancer

Explore related trials

Breast CarcinomaSolid Neoplasm

Where it's being run

16 sites across 10 states
Florida3
Texas3
California2
Ohio2
Connecticut1
Massachusetts1
New York1
Tennessee1

Who to contact

Medical Information
[email protected]
(858) 239-2944
Email the study team

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Eligibility criteria

Inclusion

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 investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. Bone only disease is allowed in dose escalation.
Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable
Adequate renal, liver, and bone marrow function

Exclusion

Patients should not have received any prior selective investigational CDK (CDK2, CDK4, CDK2/4, CDK2/4/6) inhibitors
Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease
Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps
Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
Major surgery within 4 weeks prior to first dose on study
Have received radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have active radiation pneumonitis. Patients who received radiation of \>25% of bone marrow are excluded.
Strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
History of serious cardiovascular conditions within 6 months prior to first dose on study
Unresolved toxicities from prior therapy greater than Grade 1 (per CTCAE version 5.0) (with exceptions of alopecia, vitiligo, and ≤ Grade 2 peripheral neuropathy) prior to the first dose on study
History of drug-induced pneumonitis/interstitial lung disease
Confirmed loss of function mutation or deletion of Rb1 gene
Previous high-dose chemotherapy requiring stem cell rescue

What this trial measures

  • Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)Cycle 1 (28 Days)

    Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.

  • 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)

    Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.