Trial Identifiers
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Scientific Title
A Multi-center, Open-label Phase II Study to Evaluate the Safety and Efficacy of YH003 in Combination With Toripalimab (Anti-PD-1 mAb) in Patients With Unresectable/Metastatic Melanoma and Pancreatic Ductal Adenocarcinoma (PDAC)
Commercial Sponsor
Eucure (Beijing) Biopharma Co., Ltd
Summary
This study has three experimental cohorts. Cohort 1 will enrol participants with unresectable/metastatic melanoma, who will receive YH003 in combination with toripalimab. YH003 will be dosed at RP2D every 3 weeks and toripalimab will be administered at a dose of 240mg every 3 weeks. Cohort 2 will enrol participants with unresectable/metastatic pancreatic ductal adenocarcinoma as 2nd line treatment, who will receive YH003 with toripalimab. YH003 will be dosed at RP2D every 3 weeks and toripalimab will be administered at a dose of 240mg every 3 weeks. Cohort 3 will enrol people with unresectable/metastatic pancreatic ductal adenocarcinoma as 1st line treatment, who will receive YH003 with toripalimab plus standard chemotherapy. YH003 will be dosed at RP2D every 3 weeks, toripalimab will be administered at a dose of 2540 mg every 3 weeks, Nab-paclitaxel will be administered each 21-day cycle and gemcitabine will be administered each 21-day cycle.