Biliary Tract CancerPhase 1/2NCT06938321
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
A Phase 1/2 study testing AK112 and AK130 in people with Biliary Tract Cancer, run by Akeso at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- AK112 and AK130
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able and willing to provide written informed consent.
- Have a life expectancy of at least 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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.
- 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.
- Has adequate organ function.
- 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.
- Able to to comply with all requirements of study participation (including all study procedures).
Who cannot join
- 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.
- There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
- There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
- There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
- History of severe bleeding tendency or coagulation dysfunction.
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- Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
- 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.
- Pregnant or lactating female subject.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Haitao Zhao
About this study
Official title: An Open Label, Multicenter, Phase Ib/II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
There're 2 parts in this interventional study:
- 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.
- 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
- Biliary Tract Cancer
- Being tested
- AK112, AK130
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
Following a predefined dose and date.
AK130Drug
Following a predefined dose and date.
| Study group | Role | What they receive |
|---|---|---|
| AK112 in combination with AK130 | Experimental | Not described Receives: Drug: AK112; Drug: AK130 |
| AK112 | Experimental | Not described Receives: Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.
Measured: During the first three weeks.
Number of subjects with adverse events (AEs)
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Measured: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
Objective Response Rate (ORR) (Phase II)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Measured: Through study completion, an average of 2 years.
Secondary outcomes (6)
Objective Response Rate (ORR) (Phase Ib)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Measured: Through study completion, an average of 2 years.
Disease control rate (DCR)
DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1).
Measured: Through study completion, an average of 2 years
Duration of Response (DoR)
The time from first documented evidence of CR or PR until time of first documented disease progression.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time to response (TTR)
Time between date of start of treatment until first documented response (CR or PR).
Measured: From date of randomization until the date of first documented response, assessed up to 24 months
Progression Free Survival (PFS)
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause.
Measured: Through study completion, an average of 2 years.
Overall survival (OS)
OS is defined as the time from first dose until death due to any cause
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start30 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938321
- Sponsor's protocol ID
- AK130-201
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Phase Ib/II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06938321
- Acronym / sponsor ID
- AK130-201
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There're 2 parts in this interventional study:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK112 in combination with AK130 | Experimental | Drug: AK112, Drug: AK130 |
| AK112 | Experimental | Drug: AK112 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be able and willing to provide written informed consent.
- Have a life expectancy of at least 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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.
- There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
- There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
- There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK112Following a predefined dose and date. | Drug | AK112, AK112 in combination with AK130 |
| AK130Following a predefined dose and date. | Drug | AK112 in combination with AK130 |
Primary outcome
Number of subjects with dose limiting toxicities (DLTs)
Time frame: During the first three weeks.
DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.
Number of subjects with adverse events (AEs)
Time frame: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Objective Response Rate (ORR) (Phase II)
Time frame: Through study completion, an average of 2 years.
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
6 secondary outcomes
Objective Response Rate (ORR) (Phase Ib)
Time frame: Through study completion, an average of 2 years.
Disease control rate (DCR)
Time frame: Through study completion, an average of 2 years
Duration of Response (DoR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time to response (TTR)
Time frame: From date of randomization until the date of first documented response, assessed up to 24 months
Progression Free Survival (PFS)
Time frame: Through study completion, an average of 2 years.
Overall survival (OS)
Time frame: Through study completion, an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
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Not yet recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK112 and AK130 in people with Biliary Tract Cancer, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenting Li (18116403289, wenting01.li@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with dose limiting toxicities (DLTs) (time frame: During the first three weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.