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Clinical Trials in the USA / NCT06266299
Recruiting Phase 1

A Study of KK2269 in Adult Participants With Solid Tumors

NCT06266299 · tracked via the Priya Life Science USA tracker
Sponsor
Kyowa Kirin Co., Ltd.
Phase
Phase 1
Started
2024-01-18
Last updated
2026-09-10

Condition(s) studied

Advanced Solid TumorMetastatic Solid TumorGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaEsophageal AdenocarcinomaNon Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

KK2269Docetaxel

KK2269: KK2269 administered intravenously

Docetaxel: antineoplastic drug administered intravenously

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
* 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

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Mayo Clinic Arizona Scottsdale Arizona Recruiting
City Of Hope National Medical Center Duarte California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
Washington University St Louis Missouri Recruiting
The University of Texas Southwestern Medical Center Dallas Texas Recruiting
University of Washington Seattle Washington Recruiting
Aichi Cancer Center Nagoya Aichi-ken Recruiting
Fujita Health University Hospital Toyoake Aichi-ken Recruiting
National Cancer Center Hospital East Kashiwa Chiba Recruiting
National Hospital Organization Shikoku Cancer Center Matsuyama Ehime Recruiting
Kurume University Hospital Kurume Fukuoka Recruiting
Kobe Minimally Invasive Cancer Center Kobe Hyōgo Recruiting
Kanagawa Cancer Center Yokohama Kanagawa Recruiting
Kansai Medical University Hospital Hirakata Osaka Recruiting
Kindai University Hospital Sakai Osaka Recruiting
NHO Kinki-Chuo Chest Medical Center Sakai Osaka Recruiting
Osaka Medical and Pharmaceutical University Hospital Takatsuki Osaka Recruiting
Saitama Prefectural Cancer Center Shinden Saitama Recruiting
Shizuoka Cancer Center Nagaizumi-chō Shizuoka Recruiting
Tochigi Cancer Center Utsunomiya Tochigi Recruiting
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Bunkyō-Ku Tokyo Recruiting
National Cancer Center Hospital Chuo-ku Tokyo Recruiting
Cancer Institute Hospital of JFCR Koto-Ku Tokyo Recruiting
National Hospital Organization Kyushu Cancer Center Fukuoka Japan Recruiting
Hiroshima University Hospital Hiroshima Japan Recruiting
Kumamoto University Hospital Kumamoto Japan Recruiting
Nagasaki University Hospital Nagasaki Japan Recruiting
Niigata Cancer Center Hospital Niigata Japan Recruiting
Okayama University Hospital Okayama Japan Recruiting
Osaka International Cancer Institute Osaka Japan Recruiting
Toyama University Hospital Toyama Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06266299 on ClinicalTrials.gov ↗ ← All trials in the USA