This multicenter, open-label Phase Ib/II study with dose escalation and expansion in Chinese patients with advanced solid tumors consists of Part A (SG1827 plus anti-PD-1/PD-L1) and Part B (SG1827 plus anti-PD-1/PD-L1 and bevacizumab), both evaluating safety, tolerability, PK/PD, immunogenicity, and antitumor efficacy.
This study is a multicenter, open-label, Phase Ib/II clinical trial with dose-escalation and dose-expansion components, conducted in Chinese patients with advanced malignant solid tumors. In Part A, participants will receive SG1827 in combination with an anti-PD-1/PD-L1 antibody; in Part B, participants will receive SG1827 in combination with an anti-PD-1/PD-L1 antibody and bevacizumab. Part A is designed to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), immunogenicity, and anti-tumor efficacy of SG1827 plus an anti-PD-1/PD-L1 antibody in advanced solid tumors, while Part B is designed to evaluate the safety, tolerability, PK/PD, immunogenicity, and anti-tumor efficacy of SG1827 combined with an anti-PD-1/PD-L1 antibody and bevacizumab in the same patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Intravenous infusion, once every three weeks
Intravenous infusion
Intravenous infusion
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
AEs
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0
Time frame: From first dose until 30 days after last dose of SG1827
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