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. |
| LY4052031+ Pembrolizumab (Dose-expansion, Cohort D) | EXPERIMENTAL | LY4052031 administered IV. Pembrolizumab administered IV. |
| Name | Type | Description |
|---|---|---|
| LY4052031 | DRUG | Intravenous |
| Pembrolizumab | 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 | 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 |
LY4052031 is an investigational small molecule developed by Eli Lilly and Company for advanced cancers. It is being studied in adults with metastatic solid tumors, including urothelial cancer and several other tumor types. It is in Phase 1 clinical development and is not approved for any use.
LY4052031 targets Nectin-4, a protein target. Nectin-4 is the molecular target of this small molecule, and the Phase 1 study is designed to evaluate the drug in participants whose tumors include urothelial cancer and other advanced solid tumors.
Eli Lilly and Company makes LY4052031. Lilly, which trades on the New York Stock Exchange under the ticker LLY, is the developer of the drug and sponsors its clinical program in advanced and metastatic solid tumors.
LY4052031 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The single registered trial is a Phase 1 study that is currently recruiting participants.
LY4052031 is being studied in trial NCT06465069, titled A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors. The Phase 1 trial is recruiting and plans to enroll about 460 participants across the United States, Australia, China, France, Japan, South Korea, Spain and the United Kingdom.
LY4052031 is being studied for the treatment of metastatic solid tumors. The Phase 1 trial enrolls adults with advanced or metastatic urothelial cancer and other solid tumors, including bladder cancer, triple negative breast cancer, non-small cell lung cancer, esophageal, pancreatic, ovarian, cervical, head and neck, prostate and renal pelvis cancers.