A Study of KK2269 in Adult Participants With Solid Tumors
NCT ID: NCT06266299
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
101 participants
INTERVENTIONAL
2024-01-18
2029-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1
KK2269 will be administered at each dose level, intravenous infusion.
KK2269
KK2269 administered intravenously
Part 2
KK2269 will be administered at each dose level intravenously in combination with docetaxel.
Docetaxel will be administered intravenously (Q3W).
KK2269
KK2269 administered intravenously
Docetaxel
antineoplastic drug administered intravenously
Interventions
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KK2269
KK2269 administered intravenously
Docetaxel
antineoplastic drug administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
•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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kyowa Kirin, Inc.
INDUSTRY
Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo, Japan
Countries
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Central Contacts
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Other Identifiers
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2269-001
Identifier Type: -
Identifier Source: org_study_id
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