Pancreatic CancerPhase 2NCT07114315
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
A Phase 2 study testing AK112 and AK130 in people with Pancreatic Cancer, run by Akeso at 2 sites in China.
Trial summary
This is an open-label, multi-center phase II clinical study consisting of two parts: Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- AK112 and AK130
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 19 Sep 2025to Aug 2028
- Phase
- Phase 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 80 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 or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
- According to RECIST v1.1, there is at least one measurable lesion.
- 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 90 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 PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.
- 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 systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.
- There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
- History of severe bleeding tendency or coagulation dysfunction.
- Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
- Pregnant or lactating female subject.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Liang Liu
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Jihui Hao
About this study
Official title: A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
This is an open-label, multi-center phase II clinical study consisting of two parts:
Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer.
Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- AK112, AK130
- Medical subject headings
- Pancreatic 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 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)
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 (5)
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 posted11 Aug 2025
- Study start19 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114315
- Sponsor's protocol ID
- AK130-202
- Status last verified
- Mar 2026
- First submitted
- 3 Aug 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
- A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07114315
- Acronym / sponsor ID
- AK130-202
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 11 Aug 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.
This is an open-label, multi-center phase II clinical study consisting of two parts:
Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer.
Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.
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 80 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 or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
- According to RECIST v1.1, there is at least one measurable lesion.
Key exclusion criteria (8 listed)
- Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.
- 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 systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.
- 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 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)
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).
5 secondary outcomes
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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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK112 and AK130 in people with Pancreatic Cancer, run by Akeso at 2 sites 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 8 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 2 sites 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 phase mean?
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 (+86 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 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.). The study lists 2 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.