The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
SHR-3079 injection.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDose-limiting Toxicity (DLT)
Time frame: 28 days after treatment initiation.
Maximum tolerated dose (MTD)
Time frame: Approximately 1 year.
Recommended Phase II Dose (RP2D)
Time frame: Approximately 1 year.
Types, incidence and severity of Adverse events (AEs)
Safety endpoints.
Time frame: Approximately 1 year.
Serious adverse events (SAEs)
Safety endpoints.
Time frame: Approximately 1 year.
Peak concentration (Cmax)
Pharmacokinetics (PK) Parameters.
Time frame: Approximately 1 year.
Time to peak concentration (Tmax)
Pharmacokinetics (PK) Parameters.
Time frame: Approximately 1 year.
Area under the curve (AUC0-t, AUC0-inf)
Pharmacokinetics (PK) Parameters.
Time frame: Approximately 1 year.
Half-life (t1/2)
Pharmacokinetics (PK) Parameters.
Time frame: Approximately 1 year.
Apparent clearance (CL/F)
Pharmacokinetics (PK) Parameters.
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Time frame: Approximately 1 year.
Apparent volume of distribution (Vz/F)
Pharmacokinetics (PK) Parameters.
Time frame: Approximately 1 year.
Objective Response Rate (ORR)
Preliminary efficacy endpoints.
Time frame: Approximately 1 year.
Best Overall Efficacy(BOR)
Preliminary efficacy endpoints.
Time frame: Approximately 1 year.
Time to Response (TTR)
Preliminary efficacy endpoints.
Time frame: Approximately 1 year.
Duration of Response (DoR)
Preliminary efficacy endpoints.
Time frame: Approximately 1 year.
Progression-Free Survival (PFS)
Preliminary efficacy endpoints.
Time frame: Approximately 1 year.
Overall Survival (OS)
Preliminary efficacy endpoints.
Time frame: Approximately 1 year.