Recruiting
Phase 1

KK2269

Sponsor:

Kyowa Kirin Co., Ltd.

Code:

NCT06266299

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KK2269

Docetaxel

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Esophageal Adenocarcinoma

Study ID

NCT06266299

Start date

Jan 18, 2024

Status verified date

Jan, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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 Design

Enrollment

101 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1

KK2269 will be administered at each dose level, intravenous infusion.

experimental: Part 2

KK2269 will be administered at each dose level intravenously in combination with docetaxel.

Docetaxel will be administered intravenously (Q3W).

Interventions

KK2269

KK2269 administered intravenously

Docetaxel

antineoplastic drug administered intravenously

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kyowa Kirin Co., Ltd.

+81-3-5205-7200clinical.info.jp@kyowakirin.com

Kyowa Kirin, Inc.

609-919-1100kkd.clintrial.82@kyowakirin.com

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

City Of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Washington University

Recruiting

St Louis, Missouri, United States, 63110

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Kyowa Kirin Co., Ltd.

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kyowa Kirin Co., Ltd. on 2026-01-28.