There're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK130 in combination with AK112 therapy for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced biliary tract cancer (BTC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial. 2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination with AK130 therapy or monotherapy in the treatment of advanced BTC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Following a predefined dose and date.
Following a predefined dose and date.
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGNumber of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first three weeks of treatment. DLTs 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 that occurs within the DLT observation period.
Time frame: During the first three weeks.
Number of subjects with adverse events (AEs)
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Time frame: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
Objective Response Rate (ORR) (Phase II)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Time frame: Through study completion, an average of 2 years.
Objective Response Rate (ORR) (Phase Ib)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Time frame: Through study completion, an average of 2 years.
Disease control rate (DCR)
DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1).
Time frame: Through study completion, an average of 2 years
Duration of Response (DoR)
The time from first documented evidence of CR or PR until time of first documented disease progression.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time to response (TTR)
Time between date of start of treatment until first documented response (CR or PR).
Time frame: From date of randomization until the date of first documented response, assessed up to 24 months
Progression Free Survival (PFS)
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause.
Time frame: Through study completion, an average of 2 years.
Overall survival (OS)
OS is defined as the time from first dose until death due to any cause
Time frame: Through study completion, an average of 2 years.
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