A phase II, multi-center, open-label 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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
YH003 will be dosed at RP2D every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.
Toripalimab will be administered at a dose of 240 mg every 3 weeks.
Nab-paclitaxel will be administered each 21-day cycle.
Ichan School of Medicine at Mount Sinai
New York, New York, United States
Epworth Medical Centre
Richmond, Victoria, Australia
Confirmed Objective Response Rate (ORR)
Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: up to 1 year after the last dosing
Adverse events (AE)
The safety profile of YH003 in combination with Toripalimab will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0
Time frame: up to 1 year after the last dosing
Duration of response (DOR)
To assess the antitumor activity of YH003 in combination with Toripalimab
Time frame: up to 1 year after the last dosing
Time to response (TTR)
To assess the antitumor activity of YH003 in combination with Toripalimab
Time frame: up to 1 year after the last dosing
Progression free survival (PFS)
To assess the antitumor activity of YH003 in combination with Toripalimab
Time frame: up to 1 year after the last dosing
Disease control rate (DCR)
To assess the antitumor activity of YH003 in combination with Toripalimab
Time frame: up to 1 year after the last dosing
Duration of disease control (DDC)
To assess the antitumor activity of YH003 in combination with Toripalimab
Time frame: up to 1 year after the last dosing
Overall survival (OS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Gemcitabine will be administrated each 21-day cycle.
To assess the antitumor activity of YH003 in combination with Toripalimab
Time frame: up to 1 year after the last dosing
Incidence of neutralizing antibodies (NAbs)
To assess the immunogenicity of YH003 in combination with Toripalimab
Time frame: up to 1 year after the last dosing