AVZO-023 alone or with AVZO-021 and hormone therapy for advanced HR+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AVZO-023 is an oral, selective CDK4 inhibitor being given for the first time in humans to patients with HR+/HER2- locally advanced or metastatic breast cancer. Phase 1 uses dose escalation to define safety, tolerability, pharmacokinetics, pharmacodynamics, and a recommended Phase 2 dose for AVZO-023 alone and in combination with AVZO-021 with or without endocrine therapy. Phase 2 will test antitumor activity and confirm the recommended dose in combination regimens. Key requirements include measurable disease, adequate organ function, ECOG 0-1, and no prior selective investigational CDK inhibitor exposure.

Why it matters

Who can join: the full rules

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 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

Key Exclusion Criteria:

* 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

Where it's running

• Avenzo Therapeutics Recruiting Site
  Los Angeles, California, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Los Angeles, California, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  New Haven, Connecticut, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Orlando, Florida, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Sarasota, Florida, United States Recruiting
• Avenzo Therapeutics Recruiting Site
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Medical Information
• Email: ClinicalTrials@avenzotx.com
• Phone: (858) 239-2944

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment of advanced solid tumors with AVZO-021

  This study is testing a new oral medication called AVZO-021 to see if it can safely help people with advanced solid tumors, especially certain types of breast cancer and other cancers with specific genetic changes.

  Recruiting at 13 sites Phase 1/2 Avenzo Therapeutics, Inc. · New Haven, Connecticut and 12 other locations · NCT05867251

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Dalpiciclib with an aromatase inhibitor and olmesartan as first-line therapy for HR+/HER2- advanced breast cancer

  This trial tests whether adding dalpiciclib and olmesartan to an aromatase inhibitor helps people with HR+/HER2- advanced breast cancer respond to first-line treatment.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07810088

• AI-powered pre-treatment MRI to predict chemotherapy response in HR+/HER2- breast cancer

  This study tests whether AI analysis of baseline DCE-MRI can forecast which HR+/HER2- breast cancer patients will benefit most from neoadjuvant chemotherapy.

  Recruiting at 5 sites Fujian Cancer Hospital · Fuzhou, Fujian and 4 other locations · NCT07702708

• Dalpiciclib plus hormone therapy for early HR+/HER2- breast cancer

  This trial tests whether adding dalpiciclib at two different doses and durations to standard hormone therapy helps people with early HR+/HER2- breast cancer.

  Recruiting Phase 2 Fujian Cancer Hospital · Fuzhou, Fujian and 1 other locations · NCT07581834

• BGB-43395 plus letrozole vs standard CDK4/6 inhibitor with letrozole for advanced HR+/HER2- breast cancer

  A phase 3 trial tests whether adding BGB-43395 to letrozole works better than the usual CDK4/6 inhibitor plus letrozole in adults with advanced or metastatic HR+/HER2- breast cancer who have not yet received treatment for advanced disease.

  Recruiting at 241 sites Phase 3 BeOne Medicines · Birmingham, Alabama and 240 other locations · NCT07492641

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.