AN OPEN-LABEL MULTICENTER STUDY OF LOXO-435 (LY3866288) IN ADVANCED SOLID TUMOR MALIGNANCIES WITH FGFR3 ALTERATIONS

Brief description of study

This is a study of a drug called LOXO-435 for patients with advanced solid tumors, specifically focusing on metastatic urothelial cancer (mUC) that has a change in a gene called FGFR3. The study will be conducted in two phases. Phase 1a is the first part and will test different doses of LOXO-435 to determine its safety, how well it is accepted by the patient's body, how the body processes it (pharmacokinetics), and its initial effectiveness. This phase will include patients with any type of solid tumor that has an alteration in the FGFR3 gene or its related proteins. The goal is to find the recommended dose for the next phase. Phase 1b is the second part and will involve four groups of patients receiving the recommended dose from Phase 1a. These groups will include patients with urothelial cancer, either as a single treatment or in combination with pembrolizumab (another drug), as well as patients with other types of advanced solid tumors who will receive LOXO-435 alone. The purpose is to evaluate the effectiveness and safety of LOXO-435 in these specific patient groups.


Clinical Study Identifier: s23-00192
ClinicalTrials.gov Identifier: NCT05614739
Principal Investigator: Scot Niglio.
Other Investigators: Nila Theresa De La Rosa, Elaine Shum, Laura Catherine Bauer, Eneil De La Pena, Janice Mehnert, Hank Ng, Maya Dimitrova, Minas Platon Economides, Jessica Wang, Jonathan B Kahn, Keriann M Scavone, Nina Beri, Avital Benson, David R. Wise, Salman Rafi Punekar, Katie S. Murray, Sally Lau, Nina Yang, Samantha VanMaanen, Victor Ricardo Adorno Febles, Kristen Spencer, Kathleen M Madden, Nancy Chan, Douglas K Marks.


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