RecruitingPhase 2NCT05859750

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

Sponsor

Akeso

Enrollment

78 participants

Start Date

May 25, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of AK104 (a dual immune checkpoint blocker) with standard chemotherapy as a first treatment for people with advanced pancreatic cancer that has spread and cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced or metastatic pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - You have not yet received systemic (whole-body) treatment for advanced or metastatic disease - Your cancer has at least one measurable tumor on imaging - You are in good general health with adequate organ function - You are willing to use contraception during the study **You may NOT be eligible if...** - You have already received chemotherapy for advanced/metastatic pancreatic cancer - Your cancer has spread to the brain - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK104

AK104 (6mg/kg) on day 1, IV, Q2W

DRUGAK104

AK104 (10mg/kg) on day 1, IV, Q2W

DRUGGemcitabine

Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W

DRUGNab-Paclitaxel

Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W

DRUGLiposomal 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

DRUGOxaliplatin + 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