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

Trial ID: NCT06646055

Interventional - Phase 1/2 - Active, not recruiting

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.

Conditions

• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

• AK112, Cadonilimab, nab-paclitaxel, gemcitabine
• AK112, Cadonilimab, nab-paclitaxel, gemcitabine
• AK112, Cadonilimab, nab-paclitaxel, gemcitabine
• AK112, nab-paclitaxel, gemcitabine
• nab-paclitaxel, gemcitabine

Eligibility

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.

Sponsor

Akeso

Source: ClinicalTrials.gov

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