An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 65
- 主要终点
- Progression-free survival (PFS) - Biomarker Enriched Population
研究概览
简要总结
This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abbreviated Inclusion Criteria:
- •Age 18 years or older, is willing and able to provide informed consent
- •Histologically or cytologically confirmed diagnosis of metastatic PDAC.
- •No prior systemic treatment for metastatic disease.
- •Evidence of measurable disease per RECIST 1.
- •Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Abbreviated
排除标准
- •History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
- •Use of investigational agent within 14 days prior to the first dose of study drug
- •History of autoimmune disease
- •Subject has received live vaccine within 28 days prior to the first dose of study drug
- •Has uncontrolled intercurrent illness
研究组 & 干预措施
Arm 1
TTX-030 plus nab-paclitaxel and gemcitabine
干预措施: TTX-030, nab-paclitaxel and gemcitabine (Combination Product)
Arm 2
TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
干预措施: TTX-030, budigalimab, nab-paclitaxel and gemcitabine (Combination Product)
Arm 3
Nab-Paclitaxel and gemcitabine
干预措施: Nab-Paclitaxel and gemcitabine (Combination Product)
结局指标
主要结局
Progression-free survival (PFS) - Biomarker Enriched Population
时间窗: Through study completion, an average of 1 year
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first
次要结局
- Duration of Response (DoR)(Through study completion, an average of 1 year)
- Progression-free survival (PFS) - Overall Population(Through study completion, an average of 1 year)
- Objective Response Rate (ORR)(Through study completion, an average of 1 year)
- Overall Survival (OS)(Through study completion, an average of 1 year)
- Adverse Events(Through study completion, an average of 1 year)