A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
A Multicenter, Open-label, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Combination With Chemotherapy as First-line Treatment in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
1 other identifier
interventional
78
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pancreatic-cancer
Started May 2023
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
May 16, 2023
CompletedStudy Start
First participant enrolled
May 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 16, 2024
December 1, 2024
2 years
April 14, 2023
December 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1
Up to 2 years
The number of subjects experiencing adverse events (AEs)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
From the subject signs the ICF to 90 days after the last dose of study treatment.
Secondary Outcomes (4)
Maximum observed concentration (Cmax) of AK104
From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Minimum observed concentration (Cmin) of AK104 at steady state
From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Area under the curve (AUC) of AK104
From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Study Arms (4)
AK104 6mg/kg and AG
EXPERIMENTALAK104 10mg/kg and AG
EXPERIMENTALAK104 and mFOLFIRINOX
EXPERIMENTALAK104 and NALIRIFOX
EXPERIMENTALInterventions
AK104 (6mg/kg) on day 1, IV, Q2W
Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
liposomal irinotecan 50 mg/m², oxaliplatin 60 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m², administered sequentially as a continuous intravenous infusion over 46 h
oxaliplatin, 85 mg/m²; irinotecan, 180 mg/m²; leucovorin, 400 mg/m²; and fluorouracil, 400 mg/m² given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks
Eligibility Criteria
You may qualify if:
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Patients have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; for patients who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
- Patients have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival ≥ 3 months.
- Patients who have adequate organ function.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Male patients with female partners of childbearing potential must agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.
You may not qualify if:
- Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
- Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
- Patients with known germ line BRAC1/2 mutation.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
- Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors.
- Major surgery other than the diagnosis of pancreatic cancer within 28 days prior to the first dose or major surgery is expected during the study.
- Pregnant or lactating women.
- Patients who received any prior treatments targeting the mechanism of tumor immunity.
- Patients with known contraindications to prescribed chemotherapy regimen (see instructions for specific drug).
- Patients with known medical history of severe hypersensitivity reactions to other monoclonal antibodies or intravenous gamma globulin.
- Active autoimmune disease within 2 years prior to the start of study treatmen.
- Known active pulmonary tuberculosis.
- Patients with active hepatitis B or active hepatitis C.
- Known medical history of immunodeficiency or positive HIV test.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (7)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, Hubei, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
Zhejiang Provincial People's hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2023
First Posted
May 16, 2023
Study Start
May 25, 2023
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
December 16, 2024
Record last verified: 2024-12