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New cancer drug KK2269 enters first human tests

NCT ID NCT06266299

Disease control Sponsor: Kyowa Kirin Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This early-stage trial tests the safety of a new drug called KK2269, given alone or with chemotherapy (docetaxel), in adults with advanced solid tumors that have no standard treatment options. About 101 participants will take part. The study has two parts: first testing KK2269 alone, then testing it with docetaxel in specific cancer types.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KK2269 (an experimental drug) and docetaxel (a chemotherapy drug)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early, first-in-human trial focused on safety, not effectiveness. The drug may not work or could cause serious side effects. It will take years before any potential treatment is available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 101 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus esophageal adenocarcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Esophageal adenocarcinoma Gastric adenocarcinoma Gastroesophageal junction adenocarcinoma Metastatic solid tumor Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Cancer Center

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-Ku, Tokyo, 135-8550, Japan

  • City Of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Fujita Health University Hospital

    RECRUITING

    Toyoake, Aichi-ken, 470-1192, Japan

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, 734-8551, Japan

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Kindai University Hospital

    RECRUITING

    Sakai, Osaka, 590-0197, Japan

  • Kobe Minimally Invasive Cancer Center

    RECRUITING

    Kobe, Hyōgo, 650-0046, Japan

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, 860-8556, Japan

  • Kurume University Hospital

    RECRUITING

    Kurume, Fukuoka, 830-0011, Japan

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • NHO Kinki-Chuo Chest Medical Center

    RECRUITING

    Sakai, Osaka, 591-8555, Japan

  • Nagasaki University Hospital

    RECRUITING

    Nagasaki, 852-8501, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    RECRUITING

    Fukuoka, 811-1395, Japan

  • National Hospital Organization Shikoku Cancer Center

    RECRUITING

    Matsuyama, Ehime, 791-0280, Japan

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, 951-8566, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, 700-8558, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, 541-8567, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    RECRUITING

    Takatsuki, Osaka, 569-8686, Japan

  • Saitama Prefectural Cancer Center

    RECRUITING

    Shinden, Saitama, 362-0806, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-chō, Shizuoka, 411-8777, Japan

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Tochigi Cancer Center

    RECRUITING

    Utsunomiya, Tochigi, 320-0834, Japan

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    RECRUITING

    Bunkyō-Ku, Tokyo, 113-8677, Japan

  • Toyama University Hospital

    RECRUITING

    Toyama, 930-0194, Japan

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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