NCT07114315 A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
| NCT ID | NCT07114315 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Akeso |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2027-08 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2025-09-19 with a primary completion date of 2027-08.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07114315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pancreatic 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 NCT07114315 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07114315 currently recruiting?
Yes, NCT07114315 is actively recruiting participants. Contact the research team at wenting01.li@akesobio.com for enrollment information.
Where is the NCT07114315 trial being conducted?
This trial is being conducted at Shanghai, China, Tianjin, China.
Who is sponsoring the NCT07114315 clinical trial?
NCT07114315 is sponsored by Akeso. The trial plans to enroll 160 participants.
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