This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Phase IB: SHR-A2009 will be administered intravenously,Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB. Phase II: 2 dose cohorts will be selected and it's randomization.
Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB. Phase II: RPD2 will be selected to evaluate preliminary efficacy.
Incidence of dose-limiting toxicity (DLT) (phase IB)
Time frame: 21 days after the first dose was administered to each subject.
Objective Response Rate (ORR) (phase II).
Time frame: 2 years
PK parameter: toxin-binding antibody of SHR-A2009
Time frame: through study completion, an average of 2 years
PK parameter: total antibody of SHR-A2009
Time frame: through study completion, an average of 2 years
PK parameter: free toxin of SHR-A2009
Time frame: through study completion, an average of 2 years
Plasma concentration of Adebrelimab
Time frame: through study completion, an average of 2 years
Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)
Time frame: through study completion, an average of 2 years
Duration of response(DoR )
Time frame: One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Time frame: 2 years after the last subject was enrolled in the group
Objective response rate
Time frame: 2 years after the last subject was enrolled in the group
overall survival (OS) (phase IB)
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Time frame: 3 years after the last subject was enrolled in the group
Incidence of AEs(Phase II (efficacy expansion phase))
Time frame: from Day1 to 90 days after last dose
Incidence of SAEs(Phase II (efficacy expansion phase))
Time frame: from Day1 to 90 days after last dose