This is a multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Subjects will receive AK109 by intravenous administration.
Subjects will receive AK109 in combination with paclitaxel.
Subjects will receive AK104 and AK109 in combination with paclitaxel.
Beijing Cancer Hospital
Beijing, China
RECRUITINGNumber of subjects experiencing dose-limiting toxicities (DLTs)
DLTs will be assessed during the first 28 days of treatment and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications .
Time frame: During the first 4 weeks
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: up to 2 years
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with CR or PR, based on RECIST Version 1.1.
Time frame: up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) or death from any cause (whichever occurs first)
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
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
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Subjects will receive AK104 by intravenous administration.
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 2 years
Observed pharmacokinetics (PK) exposure of AK109 and AK104
The endpoints for assessment of PK of AK109 and AK104 include serum concentrations of AK109 and AK104 at different timepoints after AK109 and AK104 administration.
Time frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 and AK109 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104