๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-15

First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer (NCT06799065)

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, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Accent Therapeutics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 in patients with advanced solid tumors and ovarian cancer.

Who can join: Review the eligibility criteria below.

Location: University of Colorado Denver โ€” Aurora, Colorado

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • University of Colorado Denver โ€” Aurora, Colorado
  • Florida Cancer Specialists โ€” Sarasota, Florida
  • Karmanos Cancer Institute โ€” Detroit, Michigan
  • University of Nebraska Medical Center โ€” Omaha, Nebraska
  • NYU Grossman School of Medicine โ€” New York, New York
  • SCRI Oncology Partners โ€” Nashville, Tennessee
  • MD Anderson Cancer Center โ€” Houston, Texas
  • NEXT Oncology โ€” San Antonio, Texas
  • NEXT Virginia โ€” Fairfax, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (339) 970-7383

Email: clinicaltrials@accenttx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—