Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY4050784 · 1 trial · 4 indications
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Number of participants with dose-limiting toxicities (DLTs)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module, ORR and Duration of Response (DOR) per Investigator
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| LY4050784 (Phase 1a - Dose Escalation) | EXPERIMENTAL | Escalating doses of LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Optimization/Part A) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Expansion/Part B) | EXPERIMENTAL | LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1 | EXPERIMENTAL | LY4050784 administered orally in combination in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a | EXPERIMENTAL | LY4050784 administered orally in combination in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b | EXPERIMENTAL | LY4050784 administered orally in combination in combination with pembrolizumab, paclitaxel/nab-paclitaxel and carboplatin administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 advanc...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
LY4050784 is an investigational small molecule developed by Eli Lilly and Company for advanced or metastatic solid tumors. It is being studied in a Phase 1 clinical trial that includes patients with non-small cell lung cancer and SMARCA4-deficient tumors. It is not yet approved for any indication.
LY4050784 targets SMARCA2, a protein in the SWI/SNF chromatin remodeling complex. The trial is biomarker-selected, enrolling patients whose tumors have specific molecular features, including SMARCA4-deficient tumors. Targeting SMARCA2 is being explored as a way to exploit vulnerabilities created by SMARCA4 loss in cancer cells.
LY4050784 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is running the clinical program for the drug in advanced and metastatic solid tumors.
LY4050784 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The single ongoing study is a Phase 1 trial evaluating the drug in participants with advanced or metastatic solid tumors.
LY4050784 is being evaluated in one clinical trial, NCT06561685, titled A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors. The Phase 1 trial is currently recruiting and plans to enroll 340 participants across the United States, France, Germany, Japan, South Korea, and Spain.
LY4050784 is being studied in advanced and metastatic solid tumors, including non-small cell lung cancer and SMARCA4-deficient tumors. The Phase 1 trial NCT06561685 enrolls adults 18 years and older and is biomarker-selected, meaning participants are chosen based on tumor molecular characteristics.