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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.
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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Bunkyō-KuJapanUnknown status
National Cancer Center Hospital
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Chuo KuJapanUnknown status
National Hospital Organization Kyushu Cancer Center
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FukuokaJapanUnknown status
Kansai Medical University Hospital
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HirakataJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Kobe Minimally Invasive Cancer Center
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KobeJapanUnknown status
Cancer Institute Hospital of JFCR
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Koto-KuJapanUnknown status
Kumamoto University Hospital
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KumamotoJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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MatsuyamaJapanUnknown status
Shizuoka Cancer Center
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Nagaizumi-chōJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
Aichi Cancer Center
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NagoyaJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Osaka International Cancer Institute
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OsakaJapanUnknown status
NHO Kinki-Chuo Chest Medical Center
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SakaiJapanUnknown status
Kindai University Hospital
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SakaiJapanUnknown status
Saitama Prefectural Cancer Center
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ShindenJapanUnknown status
Osaka Medical and Pharmaceutical University Hospital
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TakatsukiJapanUnknown status
Toyama University Hospital
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ToyamaJapanUnknown status
Fujita Health University Hospital
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ToyoakeJapanUnknown status
Tochigi Cancer Center
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UtsunomiyaJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status
The University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
City of Hope National Medical Center
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DuarteUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Hoag Memorial Hospital Presbyterian
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Newport BeachUnited StatesUnknown status
Mayo Clinic - Arizona
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ScottsdaleUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.