KK2269: KK2269 administered intravenously
Docetaxel: antineoplastic drug administered intravenously
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | Recruiting |
| City Of Hope National Medical Center | Duarte | California | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| The University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
| Aichi Cancer Center | Nagoya | Aichi-ken | Recruiting |
| Fujita Health University Hospital | Toyoake | Aichi-ken | Recruiting |
| National Cancer Center Hospital East | Kashiwa | Chiba | Recruiting |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | Recruiting |
| Kurume University Hospital | Kurume | Fukuoka | Recruiting |
| Kobe Minimally Invasive Cancer Center | Kobe | Hyōgo | Recruiting |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Recruiting |
| Kansai Medical University Hospital | Hirakata | Osaka | Recruiting |
| Kindai University Hospital | Sakai | Osaka | Recruiting |
| NHO Kinki-Chuo Chest Medical Center | Sakai | Osaka | Recruiting |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | Osaka | Recruiting |
| Saitama Prefectural Cancer Center | Shinden | Saitama | Recruiting |
| Shizuoka Cancer Center | Nagaizumi-chō | Shizuoka | Recruiting |
| Tochigi Cancer Center | Utsunomiya | Tochigi | Recruiting |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Bunkyō-Ku | Tokyo | Recruiting |
| National Cancer Center Hospital | Chuo-ku | Tokyo | Recruiting |
| Cancer Institute Hospital of JFCR | Koto-Ku | Tokyo | Recruiting |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Japan | Recruiting |
| Hiroshima University Hospital | Hiroshima | Japan | Recruiting |
| Kumamoto University Hospital | Kumamoto | Japan | Recruiting |
| Nagasaki University Hospital | Nagasaki | Japan | Recruiting |
| Niigata Cancer Center Hospital | Niigata | Japan | Recruiting |
| Okayama University Hospital | Okayama | Japan | Recruiting |
| Osaka International Cancer Institute | Osaka | Japan | Recruiting |
| Toyama University Hospital | Toyama | Japan | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06266299 on ClinicalTrials.gov ↗ ← All trials in the USA