This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial (RP2D) will be determined based on the safety, tolerability, pharmacokinetics and efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
incidence of dose-limiting toxicity (DLT)
incidence and severity of DLT
Time frame: 2 Years
incidence of adverse event(AE)
adverse events (AE)
Time frame: 2 Years
Recommended dose for phase II trial RP2D
Recommended dose for phase II trial
Time frame: 2 Years
Peak concentration (Cmax)
The highest plasma drug concentration that can be achieved after medication
Time frame: 2 years
time to peak concentration(Tmax)
The time it takes for the drug to reach its maximum concentration (Cmax) in the plasma after administration
Time frame: 2 years
elimination half life(t1/2)
The time it takes for the concentration of the drug in the plasma to be reduced by 50%
Time frame: 2 years
immunogenicity
Incidence of Anti-Drug Antibody (ADA)
Time frame: 2 years
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Time frame: 2 years
Progression free survival (PFS)
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Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Bevacizumab of 5mg/kg will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or7.5mg/kg on day 1 every 21 day cycle, based on different combined chemotherapy.
Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
The time from first dose to Disease progression or death
Time frame: 2 years
overall survival (OS)
The time from first dose to death from any cause
Time frame: 2 years