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New cancer drug LUNA18 tested in early human trial

NCT ID NCT05012618

Disease control Sponsor: Chugai Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug called LUNA18, taken as a capsule, alone or with another cancer drug (cetuximab), in 128 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety, find the right dose, and see how the drug moves through the body. The trial was terminated early, so its full results are not available.

What this could mean

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

Active substance
LUNA18 (a drug taken as a capsule) and cetuximab (given as an IV infusion)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, not on proving effectiveness. The trial was terminated, so results may not be available. Side effects are unknown and could be significant.

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

128 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 2025

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: * Age \>= 18 years at time of signing informed consent form * ECOG performance status of 0 or 1 * Patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable * Patients with documented RAS alterations positive solid tumors * Patients with measurable disease per RECIST v1.1 Exclusion Criteria: * Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months * Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases * Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection) * Patients with a history or complication of interstitial lung disease (ILD)

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As listed by the trial registrant

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

Locally advanced or metastatic solid tumors

Contacts and locations

Locations

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106, United States

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • NEXT Oncology

    Austin, Texas, 78758, United States

  • NEXT Virginia

    Fairfax, Virginia, 22031, United States

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Renown Regional Medical Center

    Reno, Nevada, 89502, United States

  • Rhode Island Hospital-Comprehensive Cancer Center

    Providence, Rhode Island, 02903, United States

  • Shizuoka Cancer Center

    Nakatogari, Shizuoka, 411-0934, Japan

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan, 49546, United States

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550, Japan

  • University of California - Davis

    Davis, California, 95616, United States

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

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