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Clinical Trials in the USA / NCT06561685
Recruiting Phase 1

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

NCT06561685 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2024-09-19
Last updated
2026-09-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

LY4050784PembrolizumabCisplatinCarboplatinPemetrexedPaclitaxelNab paclitaxel

LY4050784: Oral

Pembrolizumab: Administered IV.

Cisplatin: Administered IV.

Carboplatin: Administered IV.

Pemetrexed: Administered IV.

Paclitaxel: Administered IV.

Nab paclitaxel: Administered IV.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
UCLA Santa Monica California Recruiting
University of Colorado Health Hospital Aurora Colorado Recruiting
Sarah Cannon Research Institute at HealthOne Denver Colorado Recruiting
Florida Cancer Specialists ORLANDO/DDU Lake Mary Florida Active Not Recruiting
University of Miami Miami Florida Recruiting
University of Chicago New Lenox Illinois Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Columbia University Medical Center New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Ohio State University Hospital Columbus Ohio Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Vanderbilt-Ingram Cancer Center Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
USO-Virginia Cancer Specialists, PC Fairfax Virginia Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Institut Bergonie Bordeaux France Not Yet Recruiting
Institut Curie Paris France Recruiting
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP Villejuif France Recruiting
Charite-Universitatsmedizin Berlin Berlin Germany Recruiting
Universitaetsklinikum Essen Essen Germany Recruiting
Krankenhaus Nordwest Frankfurt am Main Germany Not Yet Recruiting
National Cancer Center Hospital Chūōku Japan Recruiting
National Cancer Center Hospital East Kashiwa Japan Recruiting
The Cancer Institute Hospital of JFCR Kōtō City Japan Recruiting
Shizuoka Cancer Center Nagaizumi-cho,Sunto-gun Japan Recruiting
Aichi Cancer Center Hospital Nagoya Japan Recruiting
National Cancer Center Ilsandong-gu South Korea Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Recruiting
The Catholic University of Korea, St. Vincent's Hospital Suwon South Korea Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Not Yet Recruiting
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz Madrid Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06561685 on ClinicalTrials.gov ↗ ← All trials in the USA