Actively Recruiting
A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
Led by Akeso · Updated on 2026-03-03
160
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced pancreatic cancer to evaluate the safety and effectiveness of two drugs, AK130 and AK112, either combined or AK112 alone. This phase II clinical trial is open-label and conducted at multiple centers. The study aims to better understand how these treatments work for patients who have already received other therapies. The trial has two parts Part I tests AK130 combined with AK112, and Part II tests AK112 alone or with AK130. Both drugs are given following a preset dosing schedule. Participants are randomly assigned to one of these treatment groups. The study will observe participants over about two years to assess treatment effects. Participants will undergo regular assessments including monitoring for side effects and checking tumor responses through measurable lesions. Researchers will track outcomes like adverse events, response rates, disease control, and survival. Safety is monitored throughout, from consent until 30 days after the last dose or start of new therapy. Participants are expected to comply with all study procedures and follow-up visits during the study period.
CONDITIONS
Brief Title
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Have histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) that has progressed on at least 2 prior systemic therapies.
- Have at least one measurable lesion according to RECIST v1.1.
- Have adequate organ function.
- Agree to use effective contraception during and for 90 days after the last dose if of reproductive potential.
- Be able to comply with all study participation requirements.
You will not qualify if you...
- Have had other malignant tumors within 5 years prior to enrollment, except pancreatic ductal adenocarcinoma.
- Have central nervous system metastasis, spinal cord compression, or meningeal metastasis.
- Have pleural effusion, pericardial effusion, or ascites with symptoms or requiring repeated drainage.
- Have prior systemic therapy with TGF-β inhibitors or anti-angiogenic agents.
- Have a history of non-infectious pneumonia requiring systemic glucocorticoid treatment.
- Have a history of severe bleeding tendency or coagulation dysfunction.
- Have a history of myocarditis, cardiomyopathy, or malignant arrhythmia.
- Be pregnant or lactating.
Research Team
W
Wenting Li
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