NextCure Starts Dose Optimization of SIM0505, Expands Trials to US, China, Canada, Europe
NextCure and Simcere Zaiming have begun dose optimization of SIM0505, a CDH6-targeting ADC, in platinum-resistant ovarian cancer and aim to finalize dose selection to de-risk registrational studies. They will expand trial sites across the US, China, Canada and Europe before presenting Phase 1 data at ASCO 2026.
1. Initiation of Dose Optimization
NextCure and Simcere Zaiming have launched the dose optimization portion of their open-label Phase 1 trial for SIM0505, targeting cadherin-6 in patients with platinum-resistant ovarian cancer. This stage is designed to finalize the recommended dose and support the transition to registrational studies.
2. Expansion of Clinical Trial Sites
The companies are increasing the number of active sites across the United States and China while adding new clinical centers in Canada and Europe. This geographic expansion is intended to accelerate patient enrollment and broaden safety and efficacy data.
3. ASCO 2026 Phase 1 Data Readout
Phase 1 data from the dose optimization cohort is scheduled for presentation at the American Society of Clinical Oncology annual meeting in 2026. The forthcoming readout will include tolerability metrics and preliminary efficacy signals to guide further development.