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New combo targets Hard-to-Treat stomach tumors

NCT ID NCT05245968

Disease control Sponsor: Taiho Pharmaceutical Co., Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug, pimitespib (TAS-116), combined with the standard drug imatinib in people with advanced gastrointestinal stromal tumors (GIST) that have stopped responding to imatinib. The study aims to find the safest dose, check for side effects, and see if the combination can slow tumor growth. About 78 participants will be enrolled across different treatment groups.

What this could mean

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

Active substance
pimitespib (TAS-116) and imatinib
What this could lead to
If successful, this combination could offer a new treatment option for people with GIST whose cancer has stopped responding to imatinib alone.
What could go wrong
This is an early Phase 1 trial with a small number of participants, so it is not yet clear if the combination is safe or effective. Side effects from the drugs may also limit their use.

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 78 people

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

Started

Dec 2021

Expected to finish

Dec 2026

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: * Provided written informed consent * Histologically confirmed GIST * Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy * Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Exclusion Criteria: * Corrected visual acuity \< 0.5 (using the International Visual Acuity Measurement Standard) for both eyes * Received treatment with any other line of therapy besides imatinib for advanced GIST * History of total gastrectomy and/or whole resection of the small intestine * A serious illness or medical condition * Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study. However, any previous cancer curatively treated \> 5 years before the enrollment can be eligible * Pregnancy or lactation (including lactation interruption)

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Conditions

The condition(s) this trial relates to.

gastrointestinal stromal tumor

As listed by the trial registrant

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

Gastrointestinal stromal tumors

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Australia

  • Beijing Cancer Hospital

    Beijing, China

  • Flinders Medical Center

    Adelaide, Australia

  • Fudan University, Shanghai Cancer Center

    Shanghai, China

  • Hokkaido University Hospital

    Hokkaido, Japan

  • Kaohsiung Medical University Hospital

    Kaohsiung City, Taiwan

  • Kumamoto University Hospital

    Kumamoto, Japan

  • Linkou Chang Gung Memorial Hospital

    Linkou District, Taiwan

  • National Cancer Center Hospital

    Tokyo, Japan

  • National Cancer Center Hospital East

    Chiba, Japan

  • National University Cancer Institute

    Singapore, Singapore

  • Osaka University Hospital

    Osaka, Japan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The Cancer Institute Hospital of JFCR

    Tokyo, Japan

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