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Promising combo for rare cancer mutation stalls as study ends early

NCT ID NCT06682806

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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-phase study tested a new drug called PRT3789 combined with the immunotherapy pembrolizumab (Keytruda) in people with advanced solid tumors that have a SMARCA4 gene mutation. The goal was to see if the combination was safe and could shrink tumors. However, the study was terminated early and only enrolled 6 participants, so we have very limited information about how well it works.

What this could mean

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

Active substance
PRT3789 and pembrolizumab (Keytruda)
What this could lead to
If it works, this combination could offer a new treatment option for people with hard-to-treat cancers that have a specific genetic change (SMARCA4 mutation).
What could go wrong
The study was terminated early and only enrolled 6 people, so there is very little data. It is too early to know if the combination is safe or effective, and it may not work at all.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

6 people

The number who actually took part.

Started

Jun 2025

Finished

Jan 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: * Patients who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures, including providing informed consent. * Patients must either progress on standard of care therapy or be ineligible for standard of care therapy in order to be eligible for enrollment on the study. * Part 1 Safety Run-in: Patients with advanced, recurrent, or metastatic histologically or cytologically confirmed solid tumor malignancy and any mutation of SMARCA4 detected by next generation sequencing in tumor tissue or blood, or absence of SMARCA4 protein (BRG1). Part 2 Main Study: Patients with advanced, recurrent, or metastatic histologically confirmed esophageal cancer or NSCLC and have a deleterious SMARCA4 mutation, or absence of SMARCA4 protein (BRG1) detected by immunohistochemistry in tumor tissue using a clinically validated laboratory test. * Part 1 Run-in: Measurable or non-measurable (but evaluable) disease per RECIST v1.1 as assessed by the local site investigator/radiologist. Part 2 Main Study: Measurable disease per RECIST v1.1 as assessed by the local site investigator/radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. * Willingness and ability to provide tumor tissue (i.e., archived or fresh tumor biopsy if archived tumor tissue is unavailable) * Adequately controlled blood pressure with or without antihypertensive medications. * Patients with HIV must have well-controlled HIV on antiretroviral therapy. * Adequate organ function Exclusion Criteria: * Patients who have adverse events due to previous anticancer therapies and/or complications from prior surgical intervention must have recovered to ≤ Grade 1 or baseline before starting study treatment. Patients with endocrine-related AEs who are adequately treated with hormone replacement or patients who have ≤ Grade 2 neuropathy are eligible. * Other acute or chronic medical or psychiatric conditions that would make the patient inappropriate for entry into this study. * Patients with solid tumors with a known concomitant SMARCA2 mutation or loss of protein expression. * Uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease and/or carcinomatous meningitis). * History of or current (noninfectious) pneumonitis/interstitial lung disease * Diagnosis of immunodeficiency disease/disorder. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Patients who received prior treatment with an agent directed to a stimulatory or co-inhibitory T-cell receptor. * Currently taking a strong or moderate CYP3A4 inhibitor or inducer and St. John's Wort and are unable to discontinue use within 15 days of the first dose of study treatment. * Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4). * Pregnant or breastfeeding or plan to become pregnant during the duration of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401, United States

  • Hospital Universitario Fundacion Jimenez Diaz - Servicio de Oncologia

    Madrid, 28040, Spain

  • IOB - Next Oncology - Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START Barcelona - HM Nou Delfos

    Barcelona, 08023, Spain

  • Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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