CRB-701 (SYS6002) - (TEMPO-1)

July 28, 2026: Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) said the FDA cleared the start of its registrational randomized controlled study TEMPO-1 evaluating CRB-701 (SYS6002), a Nectin-4–targeted antibody-drug conjugate, in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC). The company expects to initiate enrollment in September 2026.

TEMPO-1 will enroll ~250 patients and compare CRB-701 versus investigator’s choice of capecitabine, cetuximab, or docetaxel. The primary endpoint is objective response rate (ORR) intended to support potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval.

FDA clearance was supported by data from an ongoing Phase 1/2 study presented at the 2026 ASCO Annual Meeting: in 2L+ OPSCC patients treated at 3.6 mg/kg, CRB-701 achieved a confirmed ORR of 42.9%, median duration of response 6.3 months, and median progression-free survival 5.6 months (ongoing). The release also notes FDA has granted two Fast Track designations for CRB-701 in head and neck squamous cell carcinoma and cervical cancer.