A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Frequency of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- •≥18 years old and ≤ 75 years (regardless of sex).
- •ECOG performance status 0-1
- •Life expectancy longer than 3 months.
- •Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal carcinoma (PDAC).
- •No prior systemic anti-tumor therapy for metastatic PDAC.
- •Adequate organ function.
- •Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
排除标准
- •Histological or cytological diagnosis of other pathological types.
- •BRCA1/2 or PALB2 mutations.
- •Participating in another clinical research.
- •Active central nervous system (CNS) metastases.
- •Undergoing systemic antiangiogenic therapy.
- •Acute or subacute pancreatitis.
- •Other known malignancies within five years.
- •Active infection requiring systemic therapy.
研究组 & 干预措施
Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
Cadonilimab will be administered at a selected dose every 4 weeks (q4w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
干预措施: AK112, Cadonilimab, nab-paclitaxel, gemcitabine (Drug)
Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
Cadonilimab will be administered at a selected dose every 2 weeks (q2w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
干预措施: AK112, Cadonilimab, nab-paclitaxel, gemcitabine (Drug)
Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II)
Cadonilimab will be administered at a selected dose and frequency from phase Ib. AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
干预措施: AK112, Cadonilimab, nab-paclitaxel, gemcitabine (Drug)
AK112 + nab-paclitaxel + gemcitabine(phase II)
AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
干预措施: AK112, nab-paclitaxel, gemcitabine (Drug)
nab-paclitaxel + gemcitabine(phase II)
Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
干预措施: nab-paclitaxel, gemcitabine (Drug)
结局指标
主要结局
Frequency of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 28days+28days
Frequency of AEs and SAEs for all Arms in phase Ib.
Overall Response Rate (ORR)
时间窗: Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
次要结局
- Disease control rate (DCR)(Up to approximately 2 years)
- Duration of Response (DoR)(Up to approximately 2 years)
- Time to Response (TTR)(Up to approximately 2 years)
- Progression-Free Survival (PFS)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Pharmacokinetics (PK)(Up to Cycle 12)
- Anti-Drug Antibodies(ADAs)(Up to approximately 2 years)