Back to Trials
NCT06561685PHASE1Recruiting

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

Eli Lilly and Company

Start Date

9/19/2024

Completion Date

10/1/2027

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 Criteria

Age Range: 18 years to No maximum

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)

Interventions

DRUG

LY4050784

DRUG

Pembrolizumab

DRUG

Cisplatin

DRUG

Carboplatin

DRUG

Pemetrexed

DRUG

Paclitaxel

DRUG

Nab paclitaxel

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Metastatic Solid TumorAdvanced Solid TumorNon-small Cell Lung CancerSMARCA4-Deficient Tumor

Locations

UCLA

Santa Monica, California 90404

United States

University of Colorado Health Hospital

Aurora, Colorado 80045

United States

Sarah Cannon Research Institute at HealthOne

Denver, Colorado 80218

United States

Florida Cancer Specialists ORLANDO/DDU

Lake Mary, Florida 32746

United States

University of Miami

Miami, Florida 33136

United States

University of Chicago

New Lenox, Illinois 60451

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Columbia University Medical Center

New York, New York 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Ohio State University Hospital

Columbus, Ohio 43210

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee 37232-6307

United States

MD Anderson Cancer Center

Houston, Texas 77030-4009

United States

USO-Virginia Cancer Specialists, PC

Fairfax, Virginia 22031

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Institut Bergonie

Bordeaux, 33 076

France

Institut Curie

Paris, 75248

France

Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

Villejuif, 94800

France

Charite-Universitatsmedizin Berlin

Berlin, 10117

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

Krankenhaus Nordwest

Frankfurt am Main, 60488

Germany

National Cancer Center Hospital

Chūōku, 104-0045

Japan

National Cancer Center Hospital East

Kashiwa, 277-8577

Japan

The Cancer Institute Hospital of JFCR

Kōtō City, 135-8550

Japan

Shizuoka Cancer Center

Nagaizumi-cho,Sunto-gun, 411-8777

Japan

Aichi Cancer Center Hospital

Nagoya, 464-8681

Japan

National Cancer Center

Ilsandong-gu, 10408

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

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

Suwon, 16247

South Korea

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

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

Madrid, 28040

Spain