A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer

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 Details

NCT ID
NCT05859750
Phase
PHASE2
Sponsor
Akeso
Status
RECRUITING
Cancer Type
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer
Interventions
  • AK104
  • Gemcitabine
  • Nab-Paclitaxel
  • Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate
  • Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Wuhan, Hubei, China|30.58333,114.26667
  • Jinan, Shandong, China|36.66833,116.99722
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures requir…
  • 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 induct…

For full eligibility, visit ClinicalTrials.gov.

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