RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT06561685

Registry updated: 2026-09-08

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Description

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.

Interventions

LY4050784 (Drug)
Oral
Pembrolizumab (Drug)
Administered IV.
Cisplatin (Drug)
Administered IV.
Carboplatin (Drug)
Administered IV.
Pemetrexed (Drug)
Administered IV.
Paclitaxel (Drug)
Administered IV.
Nab paclitaxel (Drug)
Administered IV.

Eligibility criteria

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)

Conditions

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

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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