Corbus Pharmaceuticals received Fast Track designation from the FDA for CRB-701 in the treatment of head and neck squamous cell carcinoma.
CRB-701 is a next-generation antibody drug conjugate targeting Nectin-4 with a cleavable linker and a precise drug antibody ratio of 2.
The Phase 1/2 study's dose optimization data will be presented at ESMO 2025 next month.
Fast Track Designation
CRB-701 received Fast Track designation for recurrent head and neck squamous cell carcinoma, demonstrating potential for unmet medical need.
Phase 1/2 Study Data
The study evaluates the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors.
Upcoming Presentation
Corbus will present the Phase 1/2 study's dose optimization data at ESMO 2025 on October 19, 2025.
- The Fast Track designation expedites the drug development and review process, highlighting the significant potential of CRB-701 in addressing critical medical needs.
- The Phase 1/2 study's dose optimization data presentation at ESMO 2025 will provide crucial insights into the efficacy of CRB-701 in treating advanced solid tumors.
The FDA's Fast Track designation signifies a major step forward in the development of CRB-701 for head and neck squamous cell carcinoma. Corbus Pharmaceuticals' innovative approach underscores its commitment to advancing cancer treatments.