A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
ConditionBiliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be able and willing to provide written informed consent.
Have a life expectancy of at least 3 months.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subjects with histologically and/or cytologically confirmed advanced or metastatic biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma; excluding ampullary carcinoma), who have experienced treatment failure following prior first-line systemic therapy.
Disqualifiers
Except for BTC, the subjects had other malignant tumors within the 3 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ.
There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
Trial design
Design model
Parallel
Treatments tested in this trial
AK112
DrugFollowing a predefined dose and date.
AK130
DrugFollowing a predefined dose and date.
Treatment groups
135 Participants
are divided into 2 treatment groupsGroup A: AK112 in combination with AK130Experimental treatment 2 interventions
Group B: AK112Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number 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.2
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.3
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.Secondary outcomes
1
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.2
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 years3
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 months4
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 Source ClinicalTrials.gov