AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer

A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer

This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.

Inclusion Criteria:

1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
2. ≥18 years old and ≤ 75 years (regardless of sex).
3. ECOG performance status 0-1
4. Life expectancy longer than 3 months.
5. Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal carcinoma (PDAC).
6. No prior systemic anti-tumor therapy for metastatic PDAC.
7. Adequate organ function.
8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Exclusion Criteria:

1. Histological or cytological diagnosis of other pathological types.
2. BRCA1/2 or PALB2 mutations.
3. Participating in another clinical research.
4. Active central nervous system (CNS) metastases.
5. Undergoing systemic antiangiogenic therapy.
6. Acute or subacute pancreatitis.
7. Other known malignancies within five years.
8. Active infection requiring systemic therapy.