This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
SHR-1681 for Injection will be administrated per dose level in which the patients are assigned.
Shanghai Dongfang Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGMaximum tolerated dose (MTD)
Time frame: 12 months.
Maximum administered dose (MAD)
Time frame: 12 months.
Recommended Phase 2 dose (RP2D)
Time frame: 12 months.
Incidence and severity of adverse events (AEs)
Time frame: Approximately 3 years.
Incidence and severity of serious adverse events (SAEs)
Time frame: Approximately 3 years.
Time to maximum concentration (Tmax) of SHR-1681
Time frame: Approximately 3 years.
Maximum concentration (Cmax) of SHR-1681
Time frame: Approximately 3 years.
Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681
Time frame: Approximately 3 years.
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681
Time frame: Approximately 3 years.
Anti-SHR-1681 antibody (ADA) of SHR-1681
Time frame: Approximately 3 years.
Overall response rate (ORR)
Time frame: Approximately 3 years.
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Duration of response (DoR)
Time frame: Approximately 3 years.
Disease control rate (DCR)
Time frame: Approximately 3 years.
Progression-free survival (PFS)
Time frame: Approximately 3 years.
Overall survival (OS)
Time frame: Approximately up to 5 years after the last subject enrolled.