AK130 with AK112 for advanced biliary tract cancer

An Open Label, Multicenter, Phase Ib/II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer

This trial will test whether combining AK130 with AK112, or using AK112 alone, is safe and helps people with advanced biliary tract cancer who have not responded to first-line therapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06938321 on ClinicalTrials.gov

What this trial studies

The study has a phase Ib dose-finding portion to identify dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), and a recommended phase II dose (RP2D) for the AK130 plus AK112 combination. The phase II portion will then test the safety and anti-tumor activity of AK112 given either with AK130 or as monotherapy in patients with advanced biliary tract cancer. Eligible participants have histologically or cytologically confirmed intrahepatic or extrahepatic cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma excluded), measurable disease by RECIST v1.1, prior failure of first-line systemic therapy, and ECOG performance status 0–1. Study procedures include regular imaging and laboratory monitoring for response and toxicity, and reproductive precautions for participants of childbearing potential.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic intrahepatic or extrahepatic cholangiocarcinoma or gallbladder cancer (excluding ampullary carcinoma), ECOG 0–1, prior first-line therapy failure, measurable disease, and adequate organ function.

Not a fit: Patients with poor performance status (ECOG ≥2), life expectancy under three months, inadequate organ function, or those with ampullary carcinoma are unlikely to benefit or are ineligible.

Why it matters

Potential benefit: If successful, the regimen could provide a new treatment option that is tolerable and slows disease progression for patients with advanced biliary tract cancer after first-line therapy.

How similar studies have performed: Other trials combining immunotherapy with targeted agents have shown encouraging signals in biliary tract cancers, but these specific agents are newer and need further confirmation.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wenting Li

Conditions Biliary Tract Cancer