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NCT06266299PHASE1Recruiting

A Study of KK2269 in Adult Participants With Solid Tumors

Kyowa Kirin Co., Ltd.

Start Date

1/18/2024

Completion Date

3/1/2029

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 Criteria

Age Range: 18 years to No maximum

* 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

Interventions

DRUG

KK2269

DRUG

Docetaxel

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Conditions

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

Locations

Mayo Clinic Arizona

Scottsdale, Arizona 85259

United States

City Of Hope National Medical Center

Duarte, California 91010

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Washington University

St Louis, Missouri 63110

United States

The University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

University of Washington

Seattle, Washington 98195

United States

Aichi Cancer Center

Nagoya, Aichi-ken 464-8681

Japan

Fujita Health University Hospital

Toyoake, Aichi-ken 470-1192

Japan

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime 791-0280

Japan

Kurume University Hospital

Kurume, Fukuoka 830-0011

Japan

Kobe Minimally Invasive Cancer Center

Kobe, Hyōgo 650-0046

Japan

Kanagawa Cancer Center

Yokohama, Kanagawa 241-8515

Japan

Kansai Medical University Hospital

Hirakata, Osaka 573-1191

Japan

Kindai University Hospital

Sakai, Osaka 590-0197

Japan

NHO Kinki-Chuo Chest Medical Center

Sakai, Osaka 591-8555

Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka 569-8686

Japan

Saitama Prefectural Cancer Center

Shinden, Saitama 362-0806

Japan

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka 411-8777

Japan

Tochigi Cancer Center

Utsunomiya, Tochigi 320-0834

Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō-Ku, Tokyo 113-8677

Japan

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan

Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo 135-8550

Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395

Japan

Hiroshima University Hospital

Hiroshima, 734-8551

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Nagasaki University Hospital

Nagasaki, 852-8501

Japan

Niigata Cancer Center Hospital

Niigata, 951-8566

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

Osaka International Cancer Institute

Osaka, 541-8567

Japan

Toyama University Hospital

Toyama, 930-0194

Japan