An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.
This is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months
Subjects will receive AK104 and lenvatinib until disease progression for a maximum of 24 months
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Time frame: Up to 2 years
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Time frame: Up to 2 years
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: Up to 2 years
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: the time of informed consent signed through 90 days after the last dose of AK104 and
Observed concentrations of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Time frame: From first dose of AK104 through 90 days after last dose of AK104
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Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Time frame: From first dose of AK104 through 90 days after last dose of AK104