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.
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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Facility
City
State
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Status
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…
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
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