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New pill targets hard-to-treat cancers with specific gene flaw

NCT ID NCT07284186

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new experimental drug called PLX-61639 for people with advanced solid tumors that have a specific genetic change (SMARCA4 mutation) and have stopped responding to standard treatments. The drug is taken as a daily pill and aims to shrink or control the cancer. About 155 adults will take part to see if the drug is safe and how well it works.

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 155 people

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

Started

Dec 2025

Expected to finish

Sep 2030

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.

Key Inclusion Criteria: * Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies * Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function * Measurable disease per RECIST 1.1 * ECOG PS of 0 or 1 Key Exclusion Criteria: * Germline SMARCA4 mutations * Known SMARCA2 mutation or loss of expression * Symptomatic CNS disease * Prior treatment with another SMARCA2-directed therapy * History of other malignancies * Clinically significant heart disease * Uncontrolled hypertension * Prolongation of QT interval

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Conditions

The condition(s) this trial relates to.

adenocarcinoma Adenocarcinoma Of Esophagus esophageal adenocarcinoma esophageal squamous cell carcinoma gastric adenocarcinoma gastric squamous cell carcinoma gastroesophageal junction adenocarcinoma metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma SMARCA4-deficient sarcoma of thorax

As listed by the trial registrant

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

Advanced solid tumor Esophageal adenocarcinoma Esophageal squamous cell carcinoma Gastric adenocarcinoma Gastric squamous cell carcinoma Gastroesophageal junction (GEJ) adenocarcinoma Gastroesophageal junction squamous cell carcinoma Metastatic solid tumor Non-small cell lung carcinoma SMARCA4 mutation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. 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

  • Research Site

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Research Site

    RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    RECRUITING

    Orange, California, 92868, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    New York, New York, 10044, United States

  • Research Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Research Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Research Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

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