The primary objective is to determine the safety and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in solid tumors.
This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3809 tablet, a small molecule inhibitor of SHP2 receptor , in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Starting dose 2mg,oral administered once daily. If tolerated subsequent cohorts will test increasing doses (4mg,6mg,8mg,10mg,12mg) of SH3809.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with dose limiting toxicities (DLTs)
Incidence and nature of DLTs in the dose escalation phase
Time frame: Within the first 28 days of consecutive treatment
Maximum tolerated dose(MTD)
Time frame: Within the first 28 days of consecutive treatment
Cmax
Highest observed plasma concentration of SH3809
Time frame: 4 weeks
Tmax
Time of highest observed plasma concentration of SH3809
Time frame: 4 weeks]
T1/2
Elimination half-life of SH3809
Time frame: 4 weeks
Area Under the Curve (AUC)
Area under the plasma concentration time curve of SH3809
Time frame: 4 weeks
Overall Response Rate(ORR)
Overall response rate of SH3809 per RECIST v1.1
Time frame: up to 12 months
Progression-free survival(PFS)
Time frame: up to 12 months
Disease control rates(DCR)
Disease control rates of SH3809 per RECIST v1.1
Time frame: up to 12 months
Duration of response(DOR)
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Duration of response of SH3809 per RECIST v1.1
Time frame: up to 12 months