A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- The recommended Phase 2 dose (RP2D) of GEN-001 in patients with advanced refractory biliary tract cancer (BTC), when administered as combined with pembrolizumab or as combined with pembrolizumab and mFOLFOX.
研究概览
简要总结
This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. The safety run-in phase will be conducted before the main study phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •Be ≥19 years of age on day of signing informed consent.
- •Patient with histologically or cytologically confirmed diagnosis of unresectable, recurrent, or metastatic advanced biliary tract adenocarcinoma of the gallbladder or biliary tree (either intrahepatic or extrahepatic cholangiocarcinoma)
排除标准
- •A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (Cohort 1 only), and was discontinued from the previous IO therapy due to a Grade 3 or higher immune-related AE (irAE) (Cohort 2 and Cohort 3).
- •Is currently participating and receiving study treatments or has participated in a study of an investigational agent and received the study therapy or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- •Has had an allogeneic tissue/solid organ transplan
研究组 & 干预措施
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
Drug: GEN-001
Drug: pembrolizumab
Drug: mFOLFOX
干预措施: GEN-001 (Drug)
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
Drug: GEN-001
Drug: pembrolizumab
Drug: mFOLFOX
干预措施: Pembrolizumab (Drug)
GEN-001 with pembrolizumab or GEN-001 with pembrolizumab and mFOLFOX
Drug: GEN-001
Drug: pembrolizumab
Drug: mFOLFOX
干预措施: mFOLFOX (Drug)
结局指标
主要结局
The recommended Phase 2 dose (RP2D) of GEN-001 in patients with advanced refractory biliary tract cancer (BTC), when administered as combined with pembrolizumab or as combined with pembrolizumab and mFOLFOX.
时间窗: 1 years
Incidence of dose-limiting toxicity (DLT)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator.
时间窗: 1 years
The assessment of the anti-tumor activity per cohort
次要结局
- Incidence of Adverse Event (AE)s and laboratory abnormalities per National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v.5.0. cohort.(1 years)
- Duration of Response (DoR)(1 years)
- Progression-free Survival (PFS)(1 years)
- Overall Survival (OS)(1 years)