OncoMatch/Clinical Trials/NCT06799065
First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
Official title: A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer
Is NCT06799065 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including ATX-295 and ATX-295 and bevacizumab (or biosimilar) for advanced solid tumors.
Treatment: ATX-295 · ATX-295 and bevacizumab (or biosimilar) — The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 as a monotherapy and in combination with bevacizumab (or a biosimilar) in patients with locally advanced or metastatic solid tumors, including ovarian cancer and lung cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Tumor Agnostic
Breast Carcinoma
Ovarian Cancer
Triple-Negative Breast Cancer
Non-Small Cell Lung Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — sqNSCLC
Participants with sqNSCLC should have received prior treatment with a platinum, taxane, and checkpoint inhibitor
Must have received: taxane — sqNSCLC
Participants with sqNSCLC should have received prior treatment with a platinum, taxane, and checkpoint inhibitor
Must have received: checkpoint inhibitor — sqNSCLC
Participants with sqNSCLC should have received prior treatment with a platinum, taxane, and checkpoint inhibitor
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Colorado Denver · Aurora, Colorado
- Florida Cancer Specialists · Sarasota, Florida
- Karmanos Cancer Institute · Detroit, Michigan
- University of Nebraska Medical Center · Omaha, Nebraska
- NYU Longone Health (Long Island) · Long Island City, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06799065 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received platinum-based chemotherapy and taxane.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages