A Phase 1a/1b Study of LY4052031 an Antibody-Drug Conjugate Targeting Nectin-4 in Participants with Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Brief description of study

This is a Phase 1a/1b study testing a new drug called LY4052031 (an experimental cancer drug) in patients with advanced cancers, including bladder (urothelial) cancer, esophageal cancer, triple-negative breast cancer, non-small cell lung cancer, head and neck cancer, and prostate cancer. These cancers are being selected because they often express a protein called Nectin-4, which may help the drug target tumor cells. The main goals of the study are to evaluate the drug’s safety, how it moves through the body (PK), and whether it shows early signs of helping to slow, shrink, or control tumors.

The study has two main parts. In Phase 1a, researchers test different dose levels in small groups of patients to find the safest and most effective dose range. This phase may include about 120 to 300 participants, with small groups receiving increasing doses, along with special substudies for patients with kidney problems and those with certain genetic differences that affect drug metabolism. In Phase 1b, the chosen dose is tested in larger groups of patients, with about up to 120 participants across several expansion cohorts, to better understand safety and early signs of effectiveness in specific cancer types. Researchers will test different dose levels to find the recommended Phase 2 dose (RP2D) or optimal dose, which is the dose that balances safety with potential effectiveness.The results will help determine the best dose to use in future studies and whether LY4052031 should continue being developed as a possible treatment for these cancers.

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s26-00272
ClinicalTrials.gov Identifier: NCT06465069
Principal Investigator: Minas Platon Economides.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Maya Dimitrova, Laura Palazzolo, Andrew Laccetti, Victor Ricardo Adorno Febles, Casey E Chambers, Kenia J Rodriguez, Tiffany M Tomberlin, Doris M Salazar, Jonathan B Kahn, Carol M Lee, Morgan Geraghty Simons, Aaron Edward Katz, Mary K O'Keeffe, David R. Wise.


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