A Study of KK2269 in Adult Participants With Solid Tumors
Start Date
1/18/2024
Completion Date
3/1/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
KK2269
Docetaxel
Conditions
Locations
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
City Of Hope National Medical Center
Duarte, California 91010
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Washington University
St Louis, Missouri 63110
United States
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
University of Washington
Seattle, Washington 98195
United States
Aichi Cancer Center
Nagoya, Aichi-ken 464-8681
Japan
Fujita Health University Hospital
Toyoake, Aichi-ken 470-1192
Japan
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime 791-0280
Japan
Kurume University Hospital
Kurume, Fukuoka 830-0011
Japan
Kobe Minimally Invasive Cancer Center
Kobe, Hyōgo 650-0046
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa 241-8515
Japan
Kansai Medical University Hospital
Hirakata, Osaka 573-1191
Japan
Kindai University Hospital
Sakai, Osaka 590-0197
Japan
NHO Kinki-Chuo Chest Medical Center
Sakai, Osaka 591-8555
Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka 569-8686
Japan
Saitama Prefectural Cancer Center
Shinden, Saitama 362-0806
Japan
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka 411-8777
Japan
Tochigi Cancer Center
Utsunomiya, Tochigi 320-0834
Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo 113-8677
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo 135-8550
Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Japan
Hiroshima University Hospital
Hiroshima, 734-8551
Japan
Kumamoto University Hospital
Kumamoto, 860-8556
Japan
Nagasaki University Hospital
Nagasaki, 852-8501
Japan
Niigata Cancer Center Hospital
Niigata, 951-8566
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Osaka International Cancer Institute
Osaka, 541-8567
Japan
Toyama University Hospital
Toyama, 930-0194
Japan