NextCure, Simcere Zaiming announce expansion of Phase 1 trial of SIM0505

NextCure (NXTC) and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, announced that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial, which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors. “We are pleased by the significant progress achieved by our partner, which has enabled us to start U.S. enrollment at doses within a therapeutic range where clinical responses have already been observed. Based on current data, SIM0505 has been well tolerated with a favorable safety profile,” said Udayan Guha, M.D., Ph.D., NextCure’s chief medical officer. “We believe that SIM0505 has the potential to become a leading ADC targeting CDH6. We look forward to accelerating the ongoing trial and presenting proof-of-concept clinical data in the first half of 2026.”