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
Qualifiers
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
Treatments tested in this trial
- AK112
- AK130
Treatment groups
135 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov