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RecruitingInterventionalPhase 1

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

NCT ID: NCT06266299Sponsor: Kyowa Kirin Co., Ltd.Last updated: 2026-01-28

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.

Arms & interventions

  • DrugKK2269

    KK2269 administered intravenously

  • DrugDocetaxel

    antineoplastic drug administered intravenously

Outcome measures

Primary

  • Number of Subjects Experiencing Dose-limiting Toxicity

    Time frame: 21 days after first dose

  • Number of Adverse Events

    Time frame: From signing of ICF through study completion, an average of 1 year

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (7)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259

Recruiting

City Of Hope National Medical Center

Duarte, California, 91010

Recruiting

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Recruiting

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

Recruiting

Washington University

St Louis, Missouri, 63110

Recruiting

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Recruiting

University of Washington

Seattle, Washington, 98195

Recruiting
A Study of KK2269 in Adult Participants With Solid Tumors | Cancerify