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

Sponsor
Akeso
Study ID
NCT05859750
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AK104 — DRUG
    AK104 (6mg/kg) on day 1, IV, Q2W
  • AK104 — DRUG
    AK104 (10mg/kg) on day 1, IV, Q2W
  • Gemcitabine — DRUG
    Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
  • Nab-Paclitaxel — DRUG
    Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
  • Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate — DRUG
    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 — DRUG
    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

Study Details

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.

Key Dates

Start date
May 25, 2023
Status verified
Dec 2024
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AK104 6mg/kg and AG
  • Experimental: AK104 10mg/kg and AG
  • Experimental: AK104 and mFOLFIRINOX
  • Experimental: AK104 and NALIRIFOX

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts

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