An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations
Eli Lilly and Company
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
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugLY4050784
Oral
- DrugPembrolizumab
Administered IV.
- DrugCisplatin
Administered IV.
- DrugCarboplatin
Administered IV.
- DrugPemetrexed
Administered IV.
- DrugPaclitaxel
Administered IV.
- DrugNab paclitaxel
Administered IV.
Locations (33)
- UCLASanta Monica, California
- University of Colorado Health HospitalAurora, Colorado
- Sarah Cannon Research Institute at HealthOneDenver, Colorado
- Florida Cancer Specialists ORLANDO/DDULake Mary, Florida
- University of MiamiMiami, Florida
- University of ChicagoNew Lenox, Illinois