CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting ADC Demonstrates Encouraging Safety and Broader Efficacy in Phase 1 Study in the US and UK Presented at ASCO-GU 2025

Core Insights - Corbus Pharmaceuticals announced the presentation of data from its first-in-human dose escalation clinical study of CRB-701 at the 2025 ASCO GU symposium [1][2] - The study focuses on a next-generation antibody-drug conjugate targeting Nectin-4 in patients with metastatic urothelial cancer and other solid tumors [3][9] Study Overview - The Phase 1 Western study enrolled participants with metastatic urothelial cancer and other solid tumors associated with Nectin-4 expression, with enrollment completed in October 2024 [3] - A total of 38 participants were enrolled, with 26 evaluable for efficacy at the December 2024 data cut [3][5] - The study mirrored the top four dose cohorts used in a concurrent China study, utilizing doses of 1.8, 2.7, 3.6, and 4.5 mg/kg [3][6] Safety and Efficacy Data - CRB-701 demonstrated a favorable safety profile, with no dose-limiting toxicities observed in either the Western or China studies [6][7] - Peripheral neuropathy rates were low, with 5% in the Western study and 3% in the China study, while skin disorders were reported at 24% in the Western study compared to 8% in the China study [7] - Clinical responses were observed in multiple tumor types, including cervical cancer and head and neck squamous cell carcinoma, with notable efficacy signals [6][8][13] Future Development - The dose optimization phase has commenced, focusing on 2.7 mg/kg and 3.6 mg/kg cohorts for various tumor types [8] - The study's findings support the continued clinical development of CRB-701, particularly for tumor types expressing Nectin-4 [8][9]