This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b)
SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPhase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy
Time frame: The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months
Phase 1b: Incidence and severity of AE
Time frame: Up to follow-up period, approximately 24 months]
Phase 2: Objective response rate
Time frame: assessed up to approximately 24 months
Phase 1b: Objective response rate
Time frame: assessed up to approximately 24 months
Phase 1b: Complete response rate (CRR)
Time frame: assessed up to approximately 24 months
Phase 1b: Duration of remission (DoR)
Time frame: assessed up to approximately 24 months
Phase 1b: Progression-free survival (PFS)
Time frame: assessed up to approximately 24 months
Phase 1b: Toxin binding antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 1b: Total antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 1b: Concentration of free toxin
Time frame: Up to follow-up period, approximately 24 months
Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912
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Time frame: Up to follow-up period, approximately 24 months
Phase 2: Complete response rate (CRR)
Time frame: assessed up to approximately 24 months
Phase 2: Duration of remission (DoR)
Time frame: assessed up to approximately 24 months
Phase 2: Progression-free survival (PFS)
Time frame: assessed up to approximately 24 months
Phase 2: Incidence and severity of AE
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Toxin binding antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Total antibody to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Concentration of free toxin
Time frame: Up to follow-up period, approximately 24 months
Phase 2: Anti-drug antibodies (ADA) to SHR-A1912
Time frame: Up to follow-up period, approximately 24 months