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 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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