This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
QLS31905 injection
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose limiting toxicities(DLTs)
Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905
Time frame: 2 years
Maximum tolerated Dose(MTD)
To evaluate the safety and tolerability of QLS31905
Time frame: 2 years
Progression-free Survival (PFS)
Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
Time frame: 2 years
Objective response rate (ORR)
Objective Response Rate (ORR) is the percentage of CR+PR
Time frame: 2 years
Disease control rate (DCR)
Disease control Rate (DCR) is the percentage of CR+PR+SD
Time frame: 2 years
adverse events (AE)
To evaluate the safety and tolerability of QLS31905
Time frame: 2 years
Cmax
Maximum concentration (Cmax) of the drug after administration
Time frame: 2 years
AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Time frame: 2 years
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