NextCure receives Fast Track Designation for SIM0505 (CDH6 ADC) in ovarian cancer

CAR-T Digest - August 2020

07 April 2026: NextCure receives Fast Track Designation for SIM0505 (CDH6 ADC) in ovarian cancer

NextCure has received FDA Fast Track Designation for its ADC SIM0505 for the treatment of platinum-resistant ovarian cancer (PROC), highlighting the urgent need for better therapies in this setting
The program is currently being evaluated in an ongoing Phase 1 trial in advanced solid tumors, including ovarian cancer, with a particular focus on patients with PROC
Clinical progress is advancing, with Phase 1 data expected at ASCO 2026 and dose optimization in ovarian cancer planned for Q2 2026, supporting further development in this indication
SIM0505 is a CDH6-targeting antibody-drug conjugate with a topoisomerase 1 inhibitor payload, designed to deliver potent anti-tumor activity with an improved safety profile
With Fast Track enabling closer FDA collaboration and a potentially accelerated pathway, NextCure aims to rapidly advance SIM0505, while retaining global rights outside Greater China, where Simcere Zaiming holds regional rights