eligibility_summary
Eligible: LA/met solid tumors with actionable FGFR3 alteration (UC cohorts A2/B1–B5, non‑UC C1, A1 FGFR3/ligand). RECIST: measurable required except A1/B3. Tissue available. ECOG 0–1 (A1/A2/B3/B5) or ≤2 (B1/B2/B4/C1). Prior therapy: A1/C1 exhausted/refused/no SOC, A2/B2/B3 ≥1, B1/B4 ≥2, B5 none. FGFRi: A1/A2/B3 allowed, B1/B4 prior erdafitinib, B2/B5/C1 naïve. Exclude CNS primary/active mets, ocular disease, unresolved tox, major CV/QTcF, infection, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: LOXO-435 (LY3866288) – oral, small-molecule, highly selective FGFR3 tyrosine kinase inhibitor, Pembrolizumab – IV anti–PD-1 monoclonal antibody (immune checkpoint inhibitor), Enfortumab vedotin – IV Nectin-4–directed antibody–drug conjugate delivering MMAE (microtubule-disrupting cytotoxin). Tested as LOXO-435 monotherapy and in combinations (LOXO-435 + pembrolizumab ± enfortumab vedotin). Targets/pathways: FGFR3-altered tumor cells (mutations/fusions) and downstream signaling (e.g., MAPK/PI3K) in locally advanced/metastatic urothelial and other solid tumors, PD-1/PD-L1 immune checkpoint on T cells to enhance antitumor immunity, Nectin-4–expressing urothelial cancer cells with cytotoxic microtubule inhibition via MMAE.