First-in-Human Study of ATX-295, an Oral Drug for Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
Sponsor: Accent Therapeutics
ClinicalTrials ID:NCT06799065
This clinical trial is testing a new oral drug, ATX-295, to find a safe dose and evaluate its effects on advanced or metastatic solid tumors, including ovarian and lung cancer. The study will also test ATX-295 in combination with another cancer drug, bevacizumab.
Patient Parameters
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Program Overview
The purpose of this study is to determine a safe and well-tolerated dose of ATX-295, a new oral medication that targets a protein involved in cell division in certain cancers. Researchers will also study how the drug behaves in the body and its initial effects on tumors. The study includes testing ATX-295 alone and in combination with another cancer drug, bevacizumab, in patients with advanced or metastatic solid tumors, such as ovarian and lung cancer.
Description
ATX-295 is a new oral medication designed to block a protein called KIF18A, which plays a role in cell division in some advanced cancers. This drug has shown promising results in lab studies against various solid tumors, including ovarian cancer, lung cancer, and breast cancer.
This is the first time ATX-295 is being tested in humans. The study is in Phase 1, meaning it is primarily focused on safety and finding the right dose. Participants will receive ATX-295 alone or with bevacizumab, a drug that helps prevent the growth of blood vessels that feed tumors. Researchers will monitor how the drug is processed in the body and its effects on tumors.
The study will enroll patients with advanced ovarian cancer and lung cancer to see how well ATX-295 works and to further assess its safety. Researchers will also explore how the drug affects certain biological markers related to cancer.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic solid tumors, including ovarian cancer.
- Have tried all standard treatments that are known to work, unless the doctor decides there are no suitable options or the patient chooses not to undergo standard treatments.
- For those receiving ATX-295 alone: Must have ovarian cancer that does not respond to platinum-based treatments or cannot tolerate them. Lung cancer patients must have had previous treatments including platinum, taxane, and checkpoint inhibitors.
- For those receiving ATX-295 with bevacizumab: Must have ovarian cancer or other selected solid tumors.
- No limit on the number of previous treatments.
- Must have measurable or evaluable disease.
- Must be in good general health with an ECOG performance status of 0 or 1.
Exclusion Criteria
- Have unstable brain tumors or cancer that has spread to the brain.
- Currently receiving other cancer treatments, except hormone therapy.
- Have had major surgery within 3 weeks before starting the study.
- Have medical issues that prevent taking oral medication or affect digestion, unless they have a functioning ileostomy or colostomy.
- Have significant or uncontrolled heart disease.
- Need to take certain stomach acid-reducing medications during the study.
- Cannot stop taking certain medications that affect how the body processes drugs.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Denver | 80045 | Aurora | Colorado |
| Florida Cancer Specialists | 34232 | Sarasota | Florida |
| Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| University of Nebraska Medical Center | 68198 | Omaha | Nebraska |
| NYU Longone Health (Long Island) | 11501 | Long Island City | New York |
| NYU Longone Health (Manhattan) | 10012 | Manhattan | New York |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
| NEXT Oncology | 78229 | San Antonio | Texas |
| NEXT Virginia | 22031 | Fairfax | Virginia |
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