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New treatment option for Advanced Solid Tumor
Official title Study of AVZO-021 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05867251
What this study is testing
What is AVZO-021?
AVZO-021 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.
- Disease-related by study phase and part: i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+/HER2- breast...
- No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (excepting patients treated with an antibody-drug...
- Measurable disease as determined by RECIST version 1.1.
- Adequate bone marrow and organ function.
You likely can't join if
- Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of...
- Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For...
- Undergone major surgery within 4 weeks prior to planned start of AVZO-021.
- Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.
- Active CNS metastases or confirmed leptomeningeal disease are not eligible.
- Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \>1 at the time of...
See the full eligibility criteria
- Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.
- Disease-related by study phase and part: i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+/HER2- breast cancer, CCNE1-amplified tumors that are either epithelial ovarian cancer...
- No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (excepting patients treated with an antibody-drug conjugate, with ovarian cancer if there disease is platinum resistant or...
- Measurable disease as determined by RECIST version 1.1.
- Adequate bone marrow and organ function.
- Ability to swallow capsules or tablets. Key
- Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.
- Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted.
- Undergone major surgery within 4 weeks prior to planned start of AVZO-021.
- Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.
- Active CNS metastases or confirmed leptomeningeal disease are not eligible.
- Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \>1 at the time of starting study treatment.
- Clinically unstable cardiac function as described in the protocol.
- Any active or chronic infection/disease that compromises the immune system.
- Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.
- Active second malignancy unless in remission with life expectancy \> 2 years and with documented sponsor approval.
- Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Mineola, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
- Macquarie University, New South Wales, Australia
- Wollongong, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Sarasota, Florida, United States; Tampa, Florida, United States; Mineola, New York, United States; New York, New York, United States; Cleveland, Ohio, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.