A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer

Launched by AKESO · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for advanced biliary tract cancer, which includes cancers of the bile ducts and gallbladder. The trial has two parts. In the first part, researchers want to find out how safe a combination of two treatments, called AK130 and AK112, is and what the highest dose is that patients can tolerate without serious side effects. In the second part, they will look at how effective this combination treatment is compared to using AK112 on its own.

To participate in this trial, patients should be at least 18 years old and have advanced biliary tract cancer that has not responded to previous treatments. They should also have a life expectancy of at least three months and be able to provide written consent to join the study. Participants can expect to undergo regular check-ups and tests to monitor their health during the trial. It's important to note that certain medical conditions and past treatments may exclude some patients from joining. This trial is currently not recruiting participants, but it aims to help improve options for people with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be able and willing to provide written informed consent.
• • 2. Have a life expectancy of at least 3 months.
• • 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • 4. 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.
• • 5. According to RECIST v1.1, there is at least one untreatable measurable lesion, or a measurable lesion with clear imaging progression after local treatment, suitable for repeated and accurate measurement.
• • 6. Has adequate organ function.
• • 7. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
• • 8. Able to to comply with all requirements of study participation (including all study procedures).
• Exclusion Criteria:
• • 1. 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.
• • 2. There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
• • 3. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
• • 4. Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
• • 5. There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
• • 6. History of severe bleeding tendency or coagulation dysfunction.
• • 7. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
• • 8. Any arterial or severe venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to the first administration of medication.
• • 9. Pregnant or lactating female subject.
• • 10. Any prior or concurrent disease, treatment, or laboratory test abnormality that may confuse study results, affect subjects' full participation in the study, or may not be in their best interest to participate.