NCT06938321 A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
| NCT ID | NCT06938321 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Akeso |
| Condition | Biliary Tract Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 135 participants in total. It began in 2025-04-30 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06938321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Biliary Tract Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06938321 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06938321 currently recruiting?
Yes, NCT06938321 is actively recruiting participants. Contact the research team at wenting01.li@akesobio.com for enrollment information.
Where is the NCT06938321 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06938321 clinical trial?
NCT06938321 is sponsored by Akeso. The trial plans to enroll 135 participants.
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