NCT06561685

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	LY4050784	Oral
DRUG	Pembrolizumab	Administered IV.
DRUG	Cisplatin	Administered IV.
DRUG	Carboplatin	Administered IV.
DRUG	Pemetrexed	Administered IV.
DRUG	Paclitaxel	Administered IV.
DRUG	Nab paclitaxel	Administered IV.

Timeline

• Start date: 2024-09-19
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2024-08-20
• Last updated: 2026-03-27

Locations

31 sites across 6 countries: United States, France, Germany, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study