๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-26

A Study of KK2269 in Adult Participants With Solid Tumors (NCT06266299)

A Phase 1, Multicenter, Open-label, Dose-escalation Study Evaluating the Safety and Tolerability of Intravenous KK2269 Monotherapy and Combination Therapy With Docetaxel in Adult Participants With Solid Tumors

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Kyowa Kirin Co., Ltd.

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

This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269. In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies. In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Arizona โ€” Scottsdale, Arizona

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 (11 Sites)

  • Mayo Clinic Arizona โ€” Scottsdale, Arizona
  • City Of Hope National Medical Center โ€” Duarte, California
  • Hoag Memorial Hospital Presbyterian โ€” Newport Beach, California
  • Mayo Clinic Jacksonville โ€” Jacksonville, Florida
  • Washington University โ€” St Louis, Missouri
  • The University of Texas Southwestern Medical Center โ€” Dallas, Texas
  • University of Washington โ€” Seattle, Washington
  • Aichi Cancer Center โ€” Nagoya, Aichi-ken
  • National Cancer Center Hospital East โ€” Kashiwa, Chiba
  • National Cancer Center Hospital โ€” Chuo-ku, Tokyo
  • Cancer Institute Hospital of JFCR โ€” Koto-Ku, Tokyo

๐Ÿ“ž Contact the Study Coordinator

Phone: +81-3-5205-7200

Email: clinical.info.jp@kyowakirin.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†—