New drug targets Hard-to-Treat cancers with genetic flaw
NCT ID NCT06561685
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
32 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Aichi Cancer Center Hospital
RECRUITINGNagoya, 464-8681, Japan
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Charite-Universitatsmedizin Berlin
RECRUITINGBerlin, 10117, Germany
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Columbia University Medical Center
RECRUITINGNew York, New York, 10032, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Florida Cancer Specialists ORLANDO/DDU
ACTIVE_NOT_RECRUITINGLake Mary, Florida, 32746, United States
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Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITINGBarcelona, 08035, Spain
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Institut Bergonie
NOT_YET_RECRUITINGBordeaux, 33 076, France
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Institut Curie
RECRUITINGParis, 75248, France
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Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
RECRUITINGVillejuif, 94800, France
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Krankenhaus Nordwest
NOT_YET_RECRUITINGFrankfurt am Main, 60488, Germany
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030-4009, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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National Cancer Center
RECRUITINGIlsandong-gu, 10408, South Korea
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National Cancer Center Hospital
RECRUITINGChūōku, 104-0045, Japan
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National Cancer Center Hospital East
RECRUITINGKashiwa, 277-8577, Japan
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Ohio State University Hospital
RECRUITINGColumbus, Ohio, 43210, United States
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute at HealthOne
RECRUITINGDenver, Colorado, 80218, United States
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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Shizuoka Cancer Center
RECRUITINGNagaizumi-cho,Sunto-gun, 411-8777, Japan
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South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
RECRUITINGMadrid, 28040, Spain
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The Cancer Institute Hospital of JFCR
RECRUITINGKōtō City, 135-8550, Japan
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The Catholic University of Korea, St. Vincent's Hospital
RECRUITINGSuwon, 16247, South Korea
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UCLA
RECRUITINGSanta Monica, California, 90404, United States
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USO-Virginia Cancer Specialists, PC
RECRUITINGFairfax, Virginia, 22031, United States
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Universitaetsklinikum Essen
RECRUITINGEssen, 45147, Germany
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University of Chicago
RECRUITINGNew Lenox, Illinois, 60451, United States
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University of Colorado Health Hospital
RECRUITINGAurora, Colorado, 80045, United States
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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Vanderbilt-Ingram Cancer Center
RECRUITINGNashville, Tennessee, 37232-6307, United States
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Other studies related to the condition(s) this trial covers.
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- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors