Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug targets Hard-to-Treat cancers with rare gene mutation

NCT ID NCT05639751

Disease control Sponsor: Prelude Therapeutics 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new drug called PRT3789, alone or with chemotherapy (docetaxel), in people with advanced solid tumors that have a specific change in the SMARCA4 gene. The main goals were to check safety, find the best dose, and see if the drug shrinks tumors. 135 participants took part, and the results will guide future studies.

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

135 people

The number who actually took part.

Started

May 2023

Finished

Oct 2025

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: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures * Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of SMARCA4 (dose escalation and combination cohorts) and loss of function mutation of SMARCA4 (backfill cohorts) by local testing that have either progress on or ineligible for standard of care therapy * Must have measurable or non-measureable (but evaluable) disease per RECIST v1.1 for dose escalation and combination cohorts * Must have measureable diseases per RECIST v1.1 for backfill cohort * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Willing to provide either archival or fresh tumor tissue sample * Adequate organ function (hematology, renal, and hepatic) Exclusion Criteria: * Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression * Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease * History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study * Concurrent treatment with strong or moderate CYP3A4 inhibitor or inducer

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

metastatic malignant 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 Metastatic solid tumor Non-small cell lung cancers SMARCA4 gene mutation

Contacts and locations

Locations

  • AdventHealth Medical Group Oncology Research at Celebration

    Celebration, Florida, 34747, United States

  • Centre Leon Berard

    Lyon, 69373, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Hospital Universitario HM Sanchinarro

    Madrid, Madrid, 28050, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • NEXT Virginia

    Fairfax, Virginia, 22031, United States

  • National Cancer Centre Singapore

    Singapore, Singapore, 168583, Singapore

  • National University Hospital

    Singapore, Singapore, 119074, Singapore

  • New York Presbyterian Hospital - Columbia University Medical Center

    New York, New York, 10032, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oncopole Claudius Regaud IUCT ONCOPOLE

    Toulouse, 31059, France

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213, United States

  • START Barcelona - HM Nou Delfos

    Barcelona, Barcelona, 08023, Spain

  • START MADRID - FJD Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Madrid, 28040, Spain

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Smilow Cancer Hospital Phase 1 Unit

    New Haven, Connecticut, 06511, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • lnstitut Bergonie Centre Regionale de Lutte Contre le cancer, Service Oncologie-Medicale

    Bordeaux, 33000, France

  • lnstitut Paoli Calmettes

    Marseille, 13009, France

More trials for these conditions

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