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New cancer drug KK2260 enters first human tests

NCT ID NCT06248411

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase trial is testing a new drug called KK2260 in people with advanced solid tumors that have not responded to standard treatments. The study will first find the safest dose, then test different dosing schedules in patients with esophageal or head and neck cancers. About 189 participants will be enrolled to evaluate safety, side effects, and early signs of tumor shrinkage.

What this could mean

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

Active substance
KK2260 (an experimental drug given intravenously)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors, including esophageal and head and neck cancers.
What could go wrong
This is a very early, first-in-human study with a small number of participants. The drug may not work or could cause unexpected 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 189 people

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

Started

Nov 2023

Expected to finish

Apr 2030

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.

Inclusion Criteria: \<Common Inclusion Criteria for Part 1a, Part 1b, and Part 2 1. Patients who have given informed written consent. 2. Male or female subjects ≥18 years of age, at time of signing informed consent. 3. Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment. 4. Patients with measurable disease according to RECIST version 1.1 5. Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment 6. Subjects who agree to have a tumor biopsy as part of the baseline examination. Patients who have difficulty in performing a tumour biopsy and have agreed to submit a previously collected stored specimen. 7. Patients with an ECOG PS of 0 or 1 at baseline. 8. Patients with haematopoietic, hepatic, renal, cardiac and respiratory functions that meet certain criteria in a baseline test. \<Additional Inclusion Criteria for Part 1a 1\) Patients with pathologically diagnosed advanced or metastatic solid tumors. \<Additional Inclusion Criteria for Part 1b 1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer, or advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses. 2. Patients with pathologically diagnosed squamous cell carcinoma. 3. Patients who agree to undergo tumor biopsy after administration. \<Additional Inclusion Criteria for Part 2a 1. Patients with pathologically diagnosed with advanced or metastatic esophageal cancer. 2. Patients with pathologically diagnosed squamous cell carcinoma. 3. Patients who agree to undergo tumor biopsy after administration. \<Additional Inclusion Criteria for Part 2b 1. Patients with advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses. 2. Patients with pathologically diagnosed squamous cell carcinoma. 3. Patients who agree to undergo tumor biopsy after administration. Exclusion Criteria: \<Common Exclusion Criteria to Part 1 and Part 2\> 1. Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment. 2. Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less. 3. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs. 4. Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug. 5. Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy. 6. Patients with active interstitial lung disease or a history of active interstitial lung disease. 7. Patients with infectious diseases requiring systemic treatment. 8. Patients with a fever of 38.0°C or higher at the time of registration. 9. Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma head and neck squamous cell carcinoma metastatic malignant neoplasm

As listed by the trial registrant

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

Advanced or metastatic solid tumors

How to take part

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

  1. The places running it

    14 sites. 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 Hospital

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, Hiroshima, 734-8551, Japan

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Kobe University Hospital

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, Kumamoto, 860-8556, Japan

  • Kyushu Cancer Center

    RECRUITING

    Fukuoka, 811-1347, Japan

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, 540-0008, Japan

  • Saitama Cancer Center

    RECRUITING

    Shinden, Saitama, 362-0806, Japan

  • Shikoku Cancer Center

    RECRUITING

    Matsuyama, Ehime, 791-0280, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • Tohoku University Hospital

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.