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Can a new drug shrink Hard-to-Treat cancers? an early trial seeks answers

NCT ID NCT04511845

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This early-phase trial is testing an experimental drug called SPYK04 in people with advanced solid tumors that have stopped responding to standard treatments. The main goal is to check the drug's safety and find the right dose. Researchers will also look for early signs that SPYK04 can shrink tumors.

What this could mean

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

Active substance
an experimental drug called SPYK04
What this could lead to
If SPYK04 proves safe and shows signs of shrinking tumors, it could lead to a new treatment option for people with advanced solid cancers that have stopped responding to other therapies.
What could go wrong
This is a very early (Phase 1) trial with a small number of participants, so the drug may turn out to be ineffective or have unacceptable side effects. It is far from being a proven treatment.

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

85 people

The number who actually took part.

Started

Sep 2020

Finished

Jun 2026

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: (Both Part I and Part II) * Age \>= 18 years at time of signing informed consent form * ECOG performance status of 0 or 1 * Patients with a locally advanced, recurrent, or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable (Part I only) * Patients with measurable and/or evaluable disease per RECIST v1.1 * Patients with MAPK pathway alterations positive solid tumor (i.e., BRAF, K/N/H-RAS mutations) (Part II only) * Patients with measurable disease per RECIST v1.1 * Patients with KRAS mutated NSCLC (NSCLC cohort) * Patients with KRAS mutated Ovarian Cancer (Ovarian Cancer cohort) * Patients with RAS mutated solid tumor (Biopsy cohort) Exclusion Criteria: (Both Part I and Part II) * 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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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

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

  • Arizona Oncology

    Tucson, Arizona, 85711, United States

  • Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-Ku, Tokyo, 135-8550, Japan

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Minnesota Oncology

    Minneapolis, Minnesota, 55404, 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 Prefectural Hospital Organization Osaka International Cancer Center

    Osaka, 541-8567, Japan

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124, United States

  • Texas Oncology

    Tyler, Texas, 75702, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

More trials for these conditions

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