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

Gå till den engelska sidan

New drug targets Hard-to-Treat cancers with genetic flaw

NCT ID NCT06561685

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 3 times

Summary

This study tests a new drug, LY4050784, in people with advanced solid tumors that have a specific change in the SMARCA4 gene. The goal is to see if the drug is safe and works, either alone or with other cancer treatments. About 340 adults whose cancer has not responded to standard treatments will take part. The study lasts up to 4 years.

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 340 people

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

Started

Sep 2024

Expected to finish

Oct 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: * Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration: * Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1) * Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression. * Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression. * Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression. * Prior Systemic Therapy Criteria: * Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease. * Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease. * Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease * Measurability of disease * Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) * Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1 * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations * Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation) * Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement * Participants with history of increased risk of prolonged QT or significant arrythmia * Significant cardiovascular disease * Participants with active and/or treated for an additional primary malignancy within 2 years prior to enrolment * Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention * Participants with history of active autoimmune diseases, history of allogenic stem cell/organ transplant or compromised immune system within past 2 years (Part C only)

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.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    32 sites in 6 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 Hospital

    RECRUITING

    Nagoya, 464-8681, Japan

  • Charite-Universitatsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists ORLANDO/DDU

    ACTIVE_NOT_RECRUITING

    Lake Mary, Florida, 32746, United States

  • Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Institut Bergonie

    NOT_YET_RECRUITING

    Bordeaux, 33 076, France

  • Institut Curie

    RECRUITING

    Paris, 75248, France

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    RECRUITING

    Villejuif, 94800, France

  • Krankenhaus Nordwest

    NOT_YET_RECRUITING

    Frankfurt am Main, 60488, Germany

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Cancer Center

    RECRUITING

    Ilsandong-gu, 10408, South Korea

  • National Cancer Center Hospital

    RECRUITING

    Chūōku, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, 277-8577, Japan

  • Ohio State University Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at HealthOne

    RECRUITING

    Denver, Colorado, 80218, United States

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho,Sunto-gun, 411-8777, Japan

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtō City, 135-8550, Japan

  • The Catholic University of Korea, St. Vincent's Hospital

    RECRUITING

    Suwon, 16247, South Korea

  • UCLA

    RECRUITING

    Santa Monica, California, 90404, United States

  • USO-Virginia Cancer Specialists, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • University of Chicago

    RECRUITING

    New Lenox, Illinois, 60451, United States

  • University of Colorado Health Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232-6307, United States

More trials for these conditions

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