CSPC Pharmaceutical Group Limited (CSPC PHARMA) announced that CRB-701 (SYS6002), an antibody–drug conjugate licensed to Corbus Pharmaceuticals, has secured U.S. Food and Drug Administration clearance to initiate the registrational TEMPO-1 trial for second-line treatment of oropharyngeal squamous cell carcinoma (OPSCC).

CRB-701 is a next-generation ADC targeting the clinically validated tumour-associated antigen Nectin-4, which shows high expression in urothelial, cervical and head-and-neck squamous cell cancers. The FDA has previously granted the asset Fast Track designation for both head-and-neck squamous cell carcinoma (HNSCC) and cervical cancer.

TEMPO-1 is a randomised, controlled study comparing CRB-701 with investigator’s choice of capecitabine, cetuximab or docetaxel. Co-primary endpoints are objective response rate to support potential accelerated approval and overall survival to underpin potential full approval. Corbus plans to begin patient enrolment in the third quarter of 2026.

Regulatory clearance for TEMPO-1 is underpinned by data from an ongoing Phase I/II trial of CRB-701, results of which were presented at the 2026 American Society of Clinical Oncology Annual Meeting. Patient follow-up in that study remains in progress.