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

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.

Trial Details

NCT ID
NCT06799065
Phase
PHASE1 / PHASE2
Sponsor
Accent Therapeutics
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • ATX-295
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Detroit, Michigan, United States|42.33143,-83.04575
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Omaha, Nebraska, United States|41.25626,-95.94043

Key Eligibility Criteria

  • Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC
  • Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a can…
  • For the monotherapy expansion cohorts:
  • Participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, or platinum-intolerant

For full eligibility, visit ClinicalTrials.gov.

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