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New pill targets rare gene fault in advanced cancers

NCT ID NCT04683250

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tests a new drug called TAS0953/HM06 in people with advanced solid tumors that have specific RET gene abnormalities. The trial has two parts: Phase 1 finds the safest dose, and Phase 2 checks how well the drug shrinks tumors. About 244 adults with RET-altered non-small cell lung cancer or other solid tumors will take the drug orally twice a day in 21-day cycles.

What this could mean

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

Active substance
TAS0953/HM06 (a targeted drug that blocks the RET protein to slow or stop cancer growth)
What this could lead to
If successful, this could provide a new treatment option for people with advanced cancers that have specific RET gene changes, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause unexpected side effects. Results may not apply to all patients with RET alterations.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 244 people

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

Started

Dec 2020

Expected to finish

Mar 2031

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.

Ages Eligible for Study: \- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region) Inclusion Criteria: Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion: * Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 * Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy. If deemed appropriate by the investigator, determination on a pleural cell block or cell pellet is also acceptable. * Adequate hematopoietic, hepatic and renal function Phase I Dose-Escalation - Specific inclusion criteria: * Advanced solid tumors * Measurable and/or non-measurable disease as determined by RECIST 1.1 * If patient has brain and/or leptomeningeal metastases, (s)he should be asymptomatic. Phase I Dose-Expansion - Specific inclusion criteria: * Patient with RET gene fusion : * Cohort 1, 3: locally advanced or metastatic NSCLC patients naïve to RET selective inhibitors and no prior systemic anti-cancer treatment. Patients who have been treated with neo-adjuvant or adjuvant chemotherapy may be included if it has been completed at least 6 months prior to the first dose of the study. * Cohort 2, 4: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure to RET selective inhibitors. * Measurable disease as determined by RECIST 1.1 * If patient has brain and/or leptomeningeal metastases,(s)he should have: * asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or * asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration. Phase II : * Available RET-gene abnormalities determined on tissue or liquid biopsy * Locally advanced or metastatic: * NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors; * NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors * patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options * Eastern Cooperative Oncology Group (ECOG) performance score of 0-2 * Measurable disease as determined by RECIST 1.1 * If patient has brain and/or leptomeningeal metastases,(s)he should have: * asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or * asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration. * Adequate hematopoietic, hepatic and renal function Exclusion Criteria: Common exclusion criteria for Phase 1 and Phase 2 * Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug * Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment. * Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator. * Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion. * QT interval corrected using Fridericia's formula (QTcF) \>470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP * Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug. Phase I Dose-Expansion - and Phase II specific exclusion criteria: * Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma RET fusion positive cancer

As listed by the trial registrant

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

RET-altered non small cell lung cancer RET-altered 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

    20 sites in 3 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

    Aichi, Japan

  • Cabrini Hospital

    RECRUITING

    Malvern, Australia

  • Chao Family Comprehensive Cancer Center

    TERMINATED

    Orange, California, 92868-3298, United States

  • GenesisCare North Shore

    RECRUITING

    Saint Leonards, Australia

  • Henry Ford Hospital

    TERMINATED

    Detroit, Michigan, 48202, United States

  • Kanagawa Cancer Center

    RECRUITING

    Kanagawa, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata-shi, Osaka, Japan

  • Kindai University Hospital

    RECRUITING

    Osaka, Japan

  • Kurashiki Central Hospital

    RECRUITING

    Okayama, Japan

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

    TERMINATED

    New York, New York, 10016, United States

  • Linear Clinical Research

    RECRUITING

    Nedlands, Australia

  • Massachusetts General Hospital

    TERMINATED

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    TERMINATED

    New York, New York, 10065, United States

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, Chiba, Japan

  • National Hospital Organization Kyushu Cancer Center

    RECRUITING

    Fukuoka, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, Okayama-ken, Japan

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, Osaka, Japan

  • START Midwest - Cancer & Hematology Centers of Western Michigan

    TERMINATED

    Grand Rapids, Michigan, 49546, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Shizuoka Cancer Center

    RECRUITING

    Shizuoka, Shizuoka, Japan

  • Stanford Cancer Center

    TERMINATED

    Stanford, California, 94305-5826, United States

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The Sarah Cannon Research Institute/Tennessee Oncology

    TERMINATED

    Nashville, Tennessee, 37203, United States

  • The University of Texas M. D. Anderson Cancer Center

    TERMINATED

    Houston, Texas, 77030-4009, United States

  • Tohoku University Hospital

    RECRUITING

    Sendai, Miyagi, Japan

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