Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY4052031 · 1 trial · 14 indications
Number of participants with dose-limiting toxicities (DLTs)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
| Arm | Type | Description |
|---|---|---|
| LY4052031 (Dose-escalation, Cohort A1) | EXPERIMENTAL | Escalating doses of LY4052031 administered intravenously (IV). |
| LY4052031 (Dose-optimization, Cohort A2) | EXPERIMENTAL | Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV. |
| LY4052031 (Dose-expansion, Cohort B1, B2, C1) | EXPERIMENTAL | LY4052031 administered IV. |
| Name | Type | Description |
|---|---|---|
| LY4052031 | DRUG | Intravenous |
Inclusion Criteria: * Have one of the following solid tumor cancers: * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinom...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
LY4052031 is an investigational small molecule being studied for the treatment of metastatic solid tumors, including advanced or metastatic urothelial cancer and other solid tumors such as triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer, head and neck squamous cell carcinoma, prostate cancer, renal pelvis cancer, and bladder cancer.
LY4052031 targets Nectin-4, a protein involved in cell adhesion that is expressed on the surface of certain tumor cells. By targeting Nectin-4, the drug is designed to interfere with tumor cell signaling and growth in cancers that express this protein.
LY4052031 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy in patients with advanced or metastatic solid tumors.
LY4052031 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and potential efficacy in patients with metastatic solid tumors.
LY4052031 is being evaluated in a Phase 1 clinical trial with the identifier NCT06465069. This study is recruiting participants with advanced or metastatic urothelial cancer or other solid tumors and is being conducted in the United States, Australia, China, France, Japan, South Korea, Spain, and the United Kingdom.
LY4052031 is a distinct investigational small molecule that targets Nectin-4. It is not the same as other Nectin-4 targeting therapies, such as antibody-drug conjugates, because it is a small molecule rather than an antibody-based therapy. Its specific chemical structure and mechanism of action differentiate it from other agents in this class.