The U.S. FDA has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer

CRB-701 (SYS6002) is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4, featuring a site-specific, cleavable linker and a drug-antibody ratio of 2 with MMAE as the payload

Fast Track designation aims to expedite the development and review of drugs that address serious conditions and have the potential to meet unmet medical needs

Corbus has completed enrollment for the dose escalation phase of its Phase 1 clinical trial of CRB-701, which is being conducted in the U.S. and Europe

The Phase 1 trial, evaluating CRB-701’s safety, pharmacokinetics, and efficacy in patients with tumors expressing high levels of Nectin-4, is expected to report initial data in Q1 2025