Actively Recruiting
A 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
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Able and willing to provide written informed consent
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) progressed on at least 2 prior systemic therapies
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function
- Agree to use effective contraception during and for 90 days after last dose if of reproductive potential
- Able to comply with all study participation requirements including procedures
You will not qualify if you...
- Other malignant tumors within 5 years prior to enrollment except PDAC
- Central nervous system metastasis, spinal cord compression, or meningeal metastasis
- Pleural effusion, pericardial effusion, or ascites with symptoms or needing repeated drainage
- Prior systemic therapy with TGF-β inhibitors or anti-angiogenic agents
- History of non-infectious pneumonia requiring systemic glucocorticoids
- History of severe bleeding tendency or coagulation dysfunction
- Previous myocarditis, cardiomyopathy, or malignant arrhythmia
- Pregnant or lactating female subject
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
W
Wenting Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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