Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of KK2269 in Adult Participants With Solid Tumors
Sponsor: Kyowa Kirin Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2024-01-18
Completion Date
2029-03
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
KK2269
KK2269 administered intravenously
Docetaxel
antineoplastic drug administered intravenously
Locations (32)
Mayo Clinic Arizona
Scottsdale, Arizona, United States
City Of Hope National Medical Center
Duarte, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Washington University
St Louis, Missouri, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Kobe Minimally Invasive Cancer Center
Kobe, Hyōgo, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Sakai, Osaka, Japan
NHO Kinki-Chuo Chest Medical Center
Sakai, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Saitama Prefectural Cancer Center
Shinden, Saitama, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Japan
Kumamoto University Hospital
Kumamoto, Japan
Nagasaki University Hospital
Nagasaki, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
Osaka International Cancer Institute
Osaka, Japan
Toyama University Hospital
Toyama, Japan