Actively Recruiting
An Open Label, Multicenter Study of AK130 in Combination With AK112 for Advanced Biliary Tract Cancer Treatment
Led by Akeso · Updated on 2026-03-03
135
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AK130 combined with AK112 therapy to treat advanced biliary tract cancer (BTC) in this phase Ib/II clinical trial sponsored by Akeso. The study aims to determine the safe dose levels in phase Ib by observing dose limiting toxicities and to evaluate the safety and efficacy of these treatments in phase II. This research focuses on patients with advanced or metastatic BTC who have not responded to prior first-line treatments. The study includes two experimental treatment groups: one receiving AK112 with AK130 and the other receiving AK112 alone. Both drugs are given following predefined doses and schedules. The first phase assesses safety and tolerability to establish the recommended dose for phase II. The second phase then evaluates treatment effectiveness and safety over approximately two years. Participants will be monitored closely with regular assessments including safety evaluations from the time of consent through 30 days after treatment ends. Researchers will measure treatment responses, disease control, duration of response, time to response, progression-free survival, and overall survival. The study duration averages two years, during which participants undergo laboratory tests, imaging, and clinical exams to evaluate the treatments and monitor side effects.
CONDITIONS
Brief Title
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Life expectancy of at least 3 months
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma) after prior first-line systemic therapy failure
- At least one measurable lesion per RECIST v1.1 suitable for repeated measurement
- Adequate organ function
- Agree to use effective contraception during and for 120 days after last study treatment dose if of reproductive potential
- Able to comply with all study participation requirements
You will not qualify if you...
- Other malignant tumors within 3 years prior to enrollment, except certain cured cancers like basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ
- Central nervous system metastasis, spinal cord compression, or meningeal metastasis
- Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Prior immunotherapy targeting mechanisms other than PD-1/PD-L1 inhibitors
- History of non-infectious pneumonia requiring systemic glucocorticoids
- History of severe bleeding or coagulation disorders
- Previous myocarditis, cardiomyopathy, or malignant arrhythmia
- Recent arterial or severe venous thromboembolism or related events within 6 months before first medication dose
- Pregnant or breastfeeding women
- Any other disease, treatment, or abnormal test that could interfere with study participation or results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive AK130 in combination with AK112 or AK112 alone following a predefined dose and schedule as part of the study treatment.
Regular visits for treatment and assessment during active study drug administration
Duration - Up to 30 days after last dose and continued assessments up to 2 years
Participants are monitored for safety and efficacy after the last dose of study drug, including evaluation of adverse events and overall survival.
Approximately 6 follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Wenting Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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