Actively Recruiting
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
Led by Akeso · Updated on 2026-03-03
135
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed advanced or metastatic biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma) with prior first-line treatment failure
- At least one measurable lesion suitable for repeated measurement according to RECIST v1.1
- Adequate organ function
- Use of effective contraception during and for 120 days after last study treatment if of reproductive potential
- Able to comply with all study procedures
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, or in situ cervical or breast cancer
- Central nervous system metastasis, spinal cord compression, or meningeal metastasis
- Symptomatic or recurrent pleural, pericardial effusion, or ascites requiring 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 problems
- Previous myocarditis, cardiomyopathy, or malignant arrhythmia
- Recent arterial or severe venous thromboembolism or related serious vascular events within 6 months
- Pregnant or lactating females
- Any other medical condition, treatment, or lab abnormality that could interfere with study participation or results
AI-Screening
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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
CONTACT
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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