AK130 with AK112 for advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Wenting Li
• Email: wenting01.li@akesobio.com
• Phone: 18116403289

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.