Study on AVZO-023 Alone and with Other Treatments for Advanced Solid Tumors
Sponsor: Avenzo Therapeutics, Inc.
ClinicalTrials ID:NCT06998407
This clinical trial is testing a new oral medication, AVZO-023, to see if it is safe and effective in treating advanced solid tumors. The study will also explore how well AVZO-023 works when combined with another drug, AVZO-021, and/or hormone therapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new oral drug called AVZO-023 in patients with advanced solid tumors. AVZO-023 works by blocking a protein called CDK4, which is involved in cancer cell growth. The study will also test AVZO-023 in combination with another drug, AVZO-021, and possibly hormone therapy, to see if this combination can better control cancer.
Description
AVZO-023 is a new oral medication designed to block a protein called CDK4, which helps cancer cells grow. This study is the first to test AVZO-023 in humans. It will look at how safe and tolerable the drug is, how it moves through the body, and its effects on tumors. The study will also test AVZO-023 in combination with another drug, AVZO-021, which targets a different protein, CDK2.
In the first phase of the study, researchers will focus on finding the safest dose of AVZO-023 for patients with advanced solid tumors, including certain types of breast cancer. They will also test how well the drug works on its own and in combination with AVZO-021 and hormone therapy.
In the second phase, the study will look at how effective the combination of AVZO-023 and other treatments is in shrinking tumors in patients with specific types of breast cancer.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 years or older with a life expectancy of more than 3 months.
- Diagnosed with advanced cancer that fits the study's focus areas.
- Have measurable cancer that can be tracked during the study.
- Agree to provide test results and tumor samples for study purposes.
- Have good kidney, liver, and bone marrow function.
Exclusion Criteria
- Have not previously taken drugs that target CDK proteins.
- Do not have active cancer spread to the brain or certain other brain conditions.
- Do not have another invasive cancer or a history of such cancer treated within the last 3 years, except for certain skin cancers or other non-threatening conditions.
- Have not received cancer treatment within a specified time before starting the study.
- Have not had major surgery within 4 weeks before starting the study.
- Have not had recent radiation therapy, except under specific conditions.
- Are not taking certain medications that affect how the body processes drugs.
- Do not have serious heart conditions within the last 6 months.
- Have recovered from previous treatment side effects, except for certain mild conditions.
- Do not have a history of lung inflammation caused by drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Avenzo Therapeutics Recruiting Site | 90095 | Los Angeles | California |
| Avenzo Therapeutics Recruiting Site | 06519 | New Haven | Connecticut |
| Avenzo Therapeutics Recruiting Site | 02215 | Boston | Massachusetts |
| Avenzo Therapeutics Recruiting Site | 10016 | New York | New York |
| Avenzo Therapeutics Recruiting Site | 44106 | Cleveland | Ohio |
| Avenzo Therapeutics Recruiting Site | 77030 | Houston | Texas |
| Avenzo Therapeutics Recruiting Site | 78229 | San Antonio | Texas |
| Avenzo Therapeutics Recruiting Site | 22031 | Fairfax | Virginia |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.