This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
259
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
To evaluate the safety and tolerability of CS1001
Time frame: From first dose to 30 days after last dose of CS1001, up to 2 years
To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CS1001
Time frame: From first dose to 30 days after last dose of CS1001, up to 2 years
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