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New drug targets Hard-to-Treat cancers with MET mutations

NCT ID NCT03993873

Disease control Sponsor: Turning Point Therapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new drug called TPX-0022 in adults with advanced lung, stomach, or other solid tumors that have specific MET gene changes. The main goals are to check the drug's safety, find the best dose, and see if it shrinks tumors. About 95 participants will take the drug by mouth, and researchers will monitor side effects and how the drug moves through the body.

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

95 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Mar 2027

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: 1. Age ≥ 18 (or age ≥ 20 as required by local regulation). 2. Histological or cytological confirmation of advanced/metastatic MET exon 14 skipping mutation (METΔex14) NSCLC, MET amplified NSCLC, or MET amplified gastric cancers as determined by FISH, qPCR or NGS by local liquid biopsy or tissue, solid tumors with MET fusions or oncogenic MET mutations or MET amplified other than GI/NSCLC. 3. ECOG performance status ≤ 1. 4. Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria). 5. Subjects with asymptomatic primary CNS tumors or brain metastases are eligible for the study if they meet protocol specified criteria. 6. Adequate organ function. 7. Life expectancy ≥ 12 weeks. Exclusion Criteria: 1. Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy. 2. Presence or history of any other primary malignancy within the past 3 years other than a history of adequately treated basal or squamous cell carcinoma of the skin, or any adequately treated in situ carcinoma. 3. Major surgery within four weeks of the start of therapy. 4. Additional exclusion criteria for subjects with NSCLC with MET alterations: known oncogene mutations (eg, ALK, ROS1, KRAS, EGFR, etc.) for which there are approved therapies. 5. Additional exclusion criteria for subjects with HCC with MET alterations: liver dysfunction greater than Child-Pugh Class A. 6. Clinically significant cardiovascular disease (either active or within six months before enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of CTCAE version 5.0 grade ≥ 2. 7. Any of the following cardiac criteria: * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 470 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval 8. Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity). 9. Peripheral neuropathy ≥ Grade 2.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung gastric cancer gastric neoplasm Liver Neoplasms lung neoplasm metastatic malignant neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced solid tumor MET gene alterations Metastatic solid tumors

Contacts and locations

Locations

  • Local Institution - 2101

    Houston, Texas, 77030-4009, United States

  • Local Institution - 2102

    La Jolla, California, 92093, United States

  • Local Institution - 2103

    St Louis, Missouri, 63110, United States

  • Local Institution - 2104

    Toledo, Ohio, 43614, United States

  • Local Institution - 2105

    Denver, Colorado, 80218, United States

  • Local Institution - 2106

    Ann Arbor, Michigan, 48109, United States

  • Local Institution - 2107

    Boston, Massachusetts, 02114, United States

  • Local Institution - 2108

    Orange, California, 92868, United States

  • Local Institution - 2109

    Boston, Massachusetts, 02215, United States

  • Local Institution - 2111

    Chicago, Illinois, 60637, United States

  • Local Institution - 2112

    Fairfax, Virginia, 22031, United States

  • Local Institution - 2113

    Detroit, Michigan, 48202, United States

  • Local Institution - 4101

    Madrid, 28050, Spain

  • Local Institution - 4102

    Pamplona, 31008, Spain

  • Local Institution - 4103

    Madrid, 28040, Spain

  • Local Institution - 4104

    Madrid, 28036, Spain

  • Local Institution - 4201

    Lyon, 69008, France

  • Local Institution - 4202

    La Tronche, Auvergne-Rhône-Alpes, 38700, France

  • Local Institution - 4203

    Saint-Mandé, Val-de-Marne, 94160, France

  • Local Institution - 4204

    Villejuif, Val-de-Marne, 94805, France

  • Local Institution - 6301

    Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

  • Local Institution - 6302

    Seoul, 120-752, South Korea

  • Local Institution - 6303

    Seoul, 03080, South Korea

  • Local Institution - 6304

    Seoul, 05505, North Korea

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