RecruitingPhase 1NCT06561685

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations

Sponsor

Eli Lilly and Company

Enrollment

340 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Non-small Cell Lung Cancer SMARCA4-Deficient Tumor

Summary

The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new investigational drug called LY4050784 in patients with advanced or metastatic solid tumors that have a specific genetic change in a gene called SMARCA4 (BRG1), which regulates how cells read their DNA. **You may be eligible if...** - You have an advanced or metastatic solid tumor with a SMARCA4 (BRG1) genetic alteration confirmed by molecular testing - You have received standard treatments appropriate for your cancer, or no standard treatment is available - You have a good performance status (ECOG 0 or 1) **You may NOT be eligible if...** - Your tumor has a SMARCA2 (BRM) alteration (a different related gene) - You have untreated or uncontrolled cancer in the brain - You have significant heart disease or a history of abnormal heart rhythms (QT prolongation) - You are pregnant, breastfeeding, or plan to conceive within 6 months of the last dose Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLY4050784

Oral

DRUGPembrolizumab

Administered IV.

DRUGCisplatin

Administered IV.

DRUGCarboplatin

Administered IV.

DRUGPemetrexed

Administered IV.

DRUGPaclitaxel

Administered IV.

DRUGNab paclitaxel

Administered IV.

Locations(33)

UCLA

Santa Monica, California, United States

University of Colorado Health Hospital

Aurora, Colorado, United States

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States

Florida Cancer Specialists ORLANDO/DDU

Lake Mary, Florida, United States

University of Miami

Miami, Florida, United States

University of Chicago

New Lenox, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University Hospital

Columbus, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

USO-Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Institut Bergonie

Bordeaux, France

Institut Curie

Paris, France

Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

Villejuif, France

Charite-Universitatsmedizin Berlin

Berlin, Germany

Universitaetsklinikum Essen

Essen, Germany

Krankenhaus Nordwest

Frankfurt am Main, Germany

National Cancer Center Hospital

Chūōku, Japan

National Cancer Center Hospital East

Kashiwa, Japan

The Cancer Institute Hospital of JFCR

Kōtō City, Japan

Shizuoka Cancer Center

Nagaizumi-cho,Sunto-gun, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

National Cancer Center

Ilsandong-gu, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

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

Suwon, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

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

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06561685

Related Trials

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

NCT06692738301 locations

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

NCT0621891418 locations

A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours

NCT0683300813 locations

OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain

NCT0606804925 locations

A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours

NCT0721381712 locations