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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Advanced Solid Tumors
• Breast Cancer Recurrent
• Ovarian Cancer
• High-grade Serous Ovarian Carcinoma
• Triple Negative Breast Cancer
• sqNSCLC
• Squamous Non-small-cell Lung Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1/2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Accent Therapeutics

Last updated on ClinicalTrials.gov

October 13, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites