A Study of KK2269 in Adult Participants With Solid Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Guz można zmierzyć i śledzić badaniami
- •Ogólny stan zdrowia pozwala na участие w badaniu (0-1 w skali ECOG)
- •Oczekiwana długość życia co najmniej 3 miesiące
- •Upłynął wymagany czas po poprzednich leczeniach raka
- •Zgoda na używanie skutecznych środków antykoncepcyjnych
- •Dla części 1: Zaawansowany lub przerzutowy nowotwór (nie mózgu)
- •Dla części 2: Rak żołądka, złączenia żołądka z przełykiem, przełyku lub płuc; poprzednie leczenie raka
✗ Disqualifies
- •Niekontrolowana poważna choroba współistniejąca
- •Aktywne przerzuty do mózgu
- •Historia ciężkiej alergii na leki biologiczne (stopień 3 lub wyższy)
- •Historia chorób autoimmunologicznych
- •Obecność HIV, wirusowego zapalenia wątroby B lub C
- •Wrodzone niedobory odporności
- •Dla części 2: Wcześniejsze leczenie lekiem docetaxel
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (32)
Mayo Clinic Arizona
Scottsdale, United States
City Of Hope National Medical Center
Duarte, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Mayo Clinic Jacksonville
Jacksonville, United States
Washington University
St Louis, United States
The University of Texas Southwestern Medical Center
Dallas, United States
University of Washington
Seattle, United States
Aichi Cancer Center
Nagoya, Japan
Fujita Health University Hospital
Toyoake, Japan
National Cancer Center Hospital East
Kashiwa, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Kurume University Hospital
Kurume, Japan
Kobe Minimally Invasive Cancer Center
Kobe, Japan
Kanagawa Cancer Center
Yokohama, Japan
Kansai Medical University Hospital
Hirakata, Japan
Kindai University Hospital
Sakai, Japan
NHO Kinki-Chuo Chest Medical Center
Sakai, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan
Saitama Prefectural Cancer Center
Shinden, Japan
Shizuoka Cancer Center
Nagaizumi-chō, Japan
Tochigi Cancer Center
Utsunomiya, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Japan
National Cancer Center Hospital
Chuo-ku, Japan
Cancer Institute Hospital of JFCR
Koto-Ku, 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
Trial contact
Kyowa Kirin Co., Ltd.
Kyowa Kirin, Inc.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/11/2026.
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