This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.
This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
Shanghai Eastern Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with adverse events
Time frame: From the day of first dose to 21 days after last dose
To determine the dose limiting toxicity (DLT)
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the maximum tolerated dose(MTD)
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
To determine the recommended dose of phase II
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
Objective response rate as determined by the Invertigator using RECIST V1.1
Time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
Anti-CS1001 antibody
Time frame: From the day of first dose to 21 days after last dose
Objective response rate (ORR)
Time frame: From the day of first dose to 21 days after last dose
Overall survival(OS)
Time frame: From the day of first dose to 21 days after last dose
Progression free survival(PFS)
Time frame: From the day of first dose to 21 days after last dose
Duration of remission (DOR)
Time frame: From the day of first dose to 21 days after last dose
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