A Study of KK2269 in Adult Participants With Solid Tumors

January 26, 2026 updated by: Kyowa Kirin Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

101

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
      • Koto-Ku, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • The University of Texas Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
KK2269 will be administered at each dose level, intravenous infusion.
Drug: KK2269
KK2269 administered intravenously
Experimental: Part 2

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

Docetaxel will be administered intravenously (Q3W).
Drug: KK2269
KK2269 administered intravenously
Drug: Docetaxel
antineoplastic drug administered intravenously
Other Names:
  • Docetaxel Hydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Experiencing Dose-limiting Toxicity
Time Frame: 21 days after first dose
21 days after first dose
Number of Adverse Events
Time Frame: From signing of ICF through study completion, an average of 1 year
From signing of ICF through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Collaborators

Kyowa Kirin, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2269-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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