This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
876
Sun Yat-Sen university cancer center
Guangzhou, Guangdong, China
RECRUITINGRP2D (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
AE (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826 (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of free toxin SHR169265 (Phase 1)
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SHR-8068
Bevacizumab Injection
Fluorouracil Injection
Calcium Folinate Injection
Adebrelimab Injection
Capecitabine tablets, oral.
Time frame: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
AE (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.