A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor [CAR] T), in adult participants with advanced gastrointestinal (GI) cancers.
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). Part 1 of the study will evaluate the safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion (RDE); Part 2 will evaluate the safety and efficacy of DISP-10 in participants treated at the RDE.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma
- •Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Aged ≥18 years at time of signing informed consent
- •Adequate organ function
排除标准
- •Previous solid organ or hematopoietic cell transplant
- •Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy
- •Known history of hepatitis B or HIV infection
- •Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment
- •Known active central nervous system (CNS) metastases
- •Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis
- •Active treatment with antiviral agents
- •History of severe hypersensitivity to fludarabine or cyclophosphamide
- •Prior therapies/treatments with oncolytic viruses or T cell derived cellular therapy
研究组 & 干预措施
DISP-10
Participants will receive DV-10 in combination with ide-cel. Lymphodepleting chemotherapy (fludarabine and cyclophosphamide) will be administered a few days prior to ide-cel.
干预措施: DISP-10 (Biological)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: 90 days (2 years for related Serious Adverse Events)
Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0
Incidence of Dose Limiting Toxicities (DLTs) [PART 1]
时间窗: 28 days
Graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v6.0
Identification of the Recommended Dose for Expansion (RDE) [PART 1]
时间窗: Up to 2 years
To select the Recommended Dose for Expansion (RDE) for Part 2
Overall response rate (ORR) [PART 2]
时间窗: Up to 2 years
Confirmed complete response (CR) or partial response (PR), per RECIST v1.1
次要结局
- Overall response rate (ORR) [PART 1](Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Progression Free Survival (PFS)(Up to 2 years)
- Overall survival (OS)(Up to 15 years)
- Time to response (TTR)(Up to 2 years)
- Cellular kinetics (CK) of ide-cel(Up to 2 years)
- Pharmacokinetics of DV-10 - Cmax(Up to 2 years)
- Pharmacokinetics of DV-10 - Tmax(Up to 2 years)
- Pharmacokinetics of DV-10 - AUC(Up to 2 years)