A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
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
| Condition(s) | Metastatic Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, SMARCA4-Deficient Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 ther |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Eli Lilly and Company |
| Locations | Santa Monica, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; Lake Mary, Florida, United States; Miami, Florida, United States; New Lenox, Illinois, United States (+27 more sites) |
| Start date | 2024-09-19 |
| NCT ID | NCT06561685 |
| Official listing | https://clinicaltrials.gov/study/NCT06561685 |