Corbus Pharmaceuticals (NASDAQ: CRBP) has announced that the FDA has granted fast track designation to its next-generation Nectin-4 antibody drug conjugate CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy.
According to Corbus, this is the second fast track designation that the FDA has granted CRB-701. In December 2024, CRB-701 received fast track designation for relapsed or refractory metastatic cervical cancer.
An ongoing Phase 1/2 clinical trial is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression. Corbus plans to present the first data from its Phase 1/2 dose optimization at the European Society for Medical Oncology (ESMO) 2025 Congress on October 19, 2025.
