A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
NCT ID: NCT05859750
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
78 participants
INTERVENTIONAL
2023-05-25
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AK104 6mg/kg and AG
AK104
AK104 (6mg/kg) on day 1, IV, Q2W
Gemcitabine
Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Nab-Paclitaxel
Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
AK104 10mg/kg and AG
AK104
AK104 (10mg/kg) on day 1, IV, Q2W
Gemcitabine
Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Nab-Paclitaxel
Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
AK104 and mFOLFIRINOX
AK104
AK104 (6mg/kg) on day 1, IV, Q2W
AK104
AK104 (10mg/kg) on day 1, IV, Q2W
Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin
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
AK104 and NALIRIFOX
AK104
AK104 (6mg/kg) on day 1, IV, Q2W
AK104
AK104 (10mg/kg) on day 1, IV, Q2W
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
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
Interventions
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AK104
AK104 (6mg/kg) on day 1, IV, Q2W
AK104
AK104 (10mg/kg) on day 1, IV, Q2W
Gemcitabine
Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Nab-Paclitaxel
Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
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 + Irinotecan + 5-Fluorouracil/Leucovorin
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
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Inclusion Criteria
2. Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.
3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
4. 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.
5. 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.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Expected survival ≥ 3 months.
8. Patients who have adequate organ function.
9. 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.
Exclusion Criteria
2. Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
3. Patients with known germ line BRAC1/2 mutation.
4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
5. 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.
6. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors.
7. 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.
8. Pregnant or lactating women.
9. Patients who received any prior treatments targeting the mechanism of tumor immunity.
10. Patients with known contraindications to prescribed chemotherapy regimen (see instructions for specific drug).
11. Patients with known medical history of severe hypersensitivity reactions to other monoclonal antibodies or intravenous gamma globulin.
12. Active autoimmune disease within 2 years prior to the start of study treatmen.
13. Known active pulmonary tuberculosis.
14. Patients with active hepatitis B or active hepatitis C.
15. Known medical history of immunodeficiency or positive HIV test.
16. Patients with active infection.
17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
18. Concurrent participation in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.
19. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug, or would interfere with the evaluation of the study drug or the safety of patients, or the interpretation of the study results.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, Hubei, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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AK104-217
Identifier Type: -
Identifier Source: org_study_id