An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.
This open-label, multicenter, phase Ib/II clinical study aims to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of AK112 in combination with VG2025, in the treatment of advanced colorectal cancer with liver metastases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
The First Affiliated Hospital, Zhejiang University School of Medicine,No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province
Hangzhou, Zhejiang, China
Number of participants experiencing dose-limiting toxicities (DLTs)
Number of participants who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period
Time frame: From Day 1 to Day 28 after the first tumour vaccine was administrated in safety run-in cohorts
Number of participants with adverse events (AEs) and severity
Number of participants experiencing adverse events (AEs) and severity, graded according to CTCAE v5.0
Time frame: From ICF up to 30 days after last study treatment
Objective Response Rate (ORR)
Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1
Time frame: Time Frame: Up to 2 years
Progression free survival (PFS)
Time from the date of enrollment until the first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by RECIST version 1.1
Time frame: Up to 2 years
Disease control rate (DCR)
Proportion of participants with complete response (CR), partial response (PR), or stable disease (SD), as assessed by RECIST version 1.1
Time frame: Up to 2 years
Duration of response (DoR)
Time from the first documentation of objective response to the first documented disease progression as assessed by RECIST version 1.1 or death due to any cause, whichever occurs first
Time frame: Up to 2 years
Time to response (TTR)
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Time from the start of the treatment to the first objective tumor response observed for patients who achieved complete response (CR) or partial response (PR), as assessed by RECIST version 1.1
Time frame: Up to 2 years
Overall survival (OS)
Time from the date of enrollment to death from any cause
Time frame: Up to 2 years
Observed concentrations of AK112
Observed serum concentrations of AK112 at different time points after AK112 administration
Time frame: Up to 2 years
Number of participants with detectable anti-drug antibodies (ADAs) to AK112
Number of participants who develop detectable anti-drug antibodies (ADAs) to AK112
Time frame: Up to 2 years