AK130 combined with AK112 for advanced pancreatic 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

This is an open-label, multicenter phase II program for adults with advanced or metastatic pancreatic ductal adenocarcinoma who have progressed on no more than two prior systemic treatments. Part I gives patients the combination of AK130 plus AK112 to collect safety and early efficacy data, while Part II evaluates AK112 as monotherapy or in combination with AK130. Eligible patients must have measurable disease by RECIST v1.1, ECOG performance status 0–1, adequate organ function, and a life expectancy of at least three months. Regular imaging and safety monitoring are performed at participating oncology centers in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital Affiliated to Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Wenting Li
• Email: wenting01.li@akesobio.com
• Phone: +86 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.