Actively Recruiting
A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
Led by Akeso · Updated on 2024-12-16
78
Participants Needed
7
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.
CONDITIONS
Official Title
A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent before study procedures
- Male or female aged 18 to 75 years at consent
- Confirmed diagnosis of pancreatic ductal adenocarcinoma
- No prior systemic therapy for locally advanced or metastatic pancreatic cancer, or at least 6 months since last curative treatment if given
- At least one measurable tumor lesion per RECIST v1.1 (except certain radiotherapy-treated lesions)
- ECOG performance status of 0 or 1
- Expected survival of 3 months or more
- Adequate organ function
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use contraception during and 120 days after treatment; male partners must also use contraception during and 120 days after treatment
You will not qualify if you...
- Other types of pancreatic cancer such as acinar cell carcinoma or neuroendocrine tumors
- Active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease
- Known germ line BRAC1/2 mutation
- Symptomatic pleural, pericardial effusion, or ascites needing frequent drainage
- Signs of unacceptable disease deterioration at screening
- Active malignancies within past 3 years except study-related or cured local tumors
- Major surgery within 28 days before first dose or expected during study
- Pregnant or lactating women
- Prior treatments targeting tumor immunity mechanisms
- Known contraindications to chemotherapy used in study
- History of severe allergic reactions to monoclonal antibodies or intravenous gamma globulin
- Active autoimmune disease within 2 years before study treatment
- Active pulmonary tuberculosis
- Active hepatitis B or C infection
- History of immunodeficiency or positive HIV test
- Active infection
- History of allogeneic organ or stem cell transplantation
- Participation in another interventional clinical study unless observational or in follow-up
- Any condition posing risk or interfering with study drug evaluation or patient safety per investigator's opinion
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, Hubei, China
Actively Recruiting
4
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
5
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
7
Zhejiang Provincial People's hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Z
Zhifang Yao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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