NextCure and Simcere expand SIM0505 trial to the U.S.

* NextCure (NASDAQ:NXTC [https://seekingalpha.com/symbol/NXTC]) and Simcere Zaiming on Thursday said [https://seekingalpha.com/pr/20268668-nextcure-and-simcere-zaiming-announce-expansion-of-ongoing-phase-1-trial-of-sim0505-cdh6-adc]that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics, and efficacy in patients with advanced solid tumors.
* Multi-regional trial to accelerate time to proof-of-concept data in 1H 2026.
* SIM0505 is a novel antibody drug conjugate directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, high systemic clearance, and an improved potential therapeutic window.
* NextCure has now expanded the ongoing Phase 1 dose escalation study, which was initiated in China, by enrolling patient((s)) in the U.S. into a mid-tier dose level while dose escalation is currently advancing in China.
* NextCure acquired an exclusive global license, excluding Greater China, for SIM0505 from Simcere Zaiming.

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