This study is an open, multi-dose, dose escalation and cohort expansion, phase Ⅰ study to investigate the safety, tolerability, efficiency, pharmacokinetics, immunogenicity of SG001 in subjects with advanced tumours.
Phase Ⅰa: open, multi-dose, dose escalation. Phase Ⅰb: open, fixed-dose, cohort expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Phase Ia: Subjects will receive intravenous infusion of SG001 following a sequential dose escalation design (1mg/kg, 3mg/kg and 10mg/kg). Dose limited toxicity (DLT) will be observed within 21 days after the first administration, then subjects can continuously receive SG001 every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial. Phase Ib: Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSafety and tolerability of SG001 by assessing the percentage of participants who experience a dose-limiting toxicity (DLT)
To investigate the safety and tolerance profile tolerance profile of SG001 in subjects with advanced solid tumors
Time frame: Phase Ⅰa: 21 days
Objective response rate (ORR) in solid tumor(The ORR of cohort B, C, and E will be evaluated by Independent Review Committee).
To investigate the efficiency of SG001 in subjects with advanced solid tumors
Time frame: Phase Ⅰb: From date of first drug administration until the date of first documented progression of disease or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
Safety of SG001 in patients with advanced tumors.
To investigate the safety of SG001 in advanced tumors.
Time frame: Phase Ⅰb: From signing informed consent form (ICF) to 90 days after the last dose of study drug or initiation of a new therapy for cancer, which occurs first.
The pharmacokinetic parameters of SG001, such as Cmax, AUC, t1/2 tmax, Vss, CL (clearance rate) etc.
The pharmacokinetics(PK) profile of SG001.
Time frame: Phase Ⅰa: At the end of cycle 7(every cycle is 14 days,except cycle 1 is 21 days); Phase Ⅰb: At the end of cycle 13 (every cycle is 14 days).
The ORR of cohort B, C, and E, which will be evaluated by investigators.
The efficiency of SG001.
Time frame: From date of first drug administration until the date of first documented progression of disease (PD) or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
The ORR of cohort D, which will be evaluated by Lugano criteria 2014.
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The efficiency of SG001.
Time frame: From date of first drug administration until the date of first documented progression of disease (PD) or the date of death or the date of lose to follow-up, which occurs first, assessed up to 2 years.
DOR (duration of response).
The efficiency of SG001.
Time frame: From the date of first documentation of confirmed CR(complete response)/PR(partial response) to the date of first documentation of PD or the date of death from any cause or the date of lose to follow-up, which occurs first, assessed up to 2 years.
DCR (disease control rate).
The efficiency of SG001.
Time frame: DCR is defined as the percentage of patients with best overall response of CR, PR, or SD(stable disease), which will be assessed up to 2 years.
TTP (time to progression).
The efficiency of SG001.
Time frame: From the date of first drug administration to the date of first documentation of PD, assessed up to 2 years.
PFS (free-progression survival).
The efficiency of SG001.
Time frame: From date of first drug administration until the date of first documented progression of disease (PD) or the date of death, which occurs first, assessed up to 2 years.
OS (overall survival).
The efficiency of SG001.
Time frame: From date of first drug administration until the date of death, assessed up to 2 years.
Immunogenicity of SG001.
The immune profile of SG001.
Time frame: From the first dose of study drug to 28 days after its last dose.
The activated T cell receptor occupancy.
The pharmacodynamics of SG001.
Time frame: Phase Ⅰa: At the end of cycle 7(every cycle is 14 days,except cycle 1 is 21 days); Phase Ⅰb: At the end of cycle 13 (every cycle is 14 days).