NCT06266299Active, not recruitingPhase 1
A Study of KK2269 in Adult Participants With Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 83 (actual)
- First submitted
- 5 Feb 2024
- Start date
- 18 Jan 2024
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Diseases
- Lung cancer, Gastric and esophageal cancer
- NCT number
- NCT06266299
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 83
- From 18 Jan 2024 to the primary completion date, 31 Mar 2029
- 32 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Key Common Inclusion Criteria for Parts 1 and 2:
- Patients who are ≥ 18 years old at the time of informed consent
- Patients who have disease measurable by RECIST v1.1
- Patients with an ECOG PS of 0 or 1
- Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator
- The specified periods have passed respectively after the completion of previous cancer treatments as of the date of enrollment at the time of the first dose of KK2269
- Patients who agree to use a medically effective method of contraception
- Key Additional Inclusion Criterion for Part 1:
- •Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor
- Key Additional Inclusion Criteria for Part 2:
- •Patients with histological or cytological evidence of any of the following disease: Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma, NSCLC (Only patients with NSCLC will be enrolled in the expansion part)
- •Patients who are suitable for docetaxel treatment
- Key Common Exclusion Criteria for Parts 1 and 2:
- Patients with an uncontrolled or serious intercurrent illness
- Patients with known active central nervous system metastasis
- Patients with a history of ≥ Grade 3 allergic reaction to any antibody drug
- Patients with a history of autoimmune disease
- Patients with a history of HIV, HBV, or HCV at screening
- Patients who have a history of primary immunodeficiency
- Key Additional Exclusion Criterion For Part 2:
- Patients with a history of treatment with docetaxel
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| National Hospital Organization Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Kobe Minimally Invasive Cancer Center Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-Ku | Japan | Unknown status |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nagaizumi-chō | Japan | Unknown status |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| NHO Kinki-Chuo Chest Medical Center Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Saitama Prefectural Cancer Center Coordinator of this site? Confirm its status | Shinden | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Tochigi Cancer Center Coordinator of this site? Confirm its status | Utsunomiya | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| The University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.