This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for injection in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
SHR-9803
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China
Dose Limited Toxicity(Ia)
Time frame: Screening up to the end of phase Ia, an average of 6 months
Dose Limited Toxicity (Ib)
Time frame: Screening up to the end of phase Ib, an average of 1 year
Recommended phase II dose(Ib)
Time frame: Screening up to the end of phase Ib, an average of 2 years
objective response rate(II)
Time frame: Screening up to study completion, an average of 3 year
Adverse Events,
Time frame: Screening up to study completion, an average of 3 year;
Disease Control Rate (DCR),
Time frame: Screening up to study completion, an average of 3 year
Progression-Free Survival (PFS),
Time frame: Screening up to study completion, an average of 3 year;
Plasma concentration of SHR-9803
Time frame: Screening up to study completion, an average of 3 year;
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