An Open-label, Phase Ib Study to Assess the Safety and Clinical Activity of CYAD-101 Administered Concurrently With FOLFOX Chemotherapy, Followed by Pembrolizumab Treatment, in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period'
研究概览
简要总结
The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.
详细描述
This Study aims to provide insight into whether CYAD-101 administration concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment might be a treatment option for patients with unresectable metastatic colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 proven metastatic adenocarcinoma of the colon or rectum.
- •Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
- •Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status
- •Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- •Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy
- •The patient is due to receive FOLFOX chemotherapy
- •Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Adequate organ, hepatic, renal, pulmonary and cardiac functions
- •Tumor biopsy at screening
排除标准
- •Any other investigational agent or device within 4 weeks of the first study treatment administration.
- •Any anticancer agent within 4 weeks of the first study treatment administration
- •Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days of the first study treatment administration
- •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
- •Prior radiotherapy within 2 weeks prior to the planned day for the first study treatment administration
- •Major surgery within 4 weeks before the planned day for the first study treatment administration
- •A live vaccine within 30 days prior to the planned day for the first study treatment administration
- •Uncontrolled intercurrent illness or serious uncontrolled medical disorder
- •Patients with history of (non-infectious) pneumonitis that require steroids or has current pneumonitis as assessed by chest imaging within 48 hours prior to first study treatment administration.
研究组 & 干预措施
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
干预措施: CYAD-101 (Drug)
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
干预措施: FOLFOX (Drug)
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period'
时间窗: Up to 73 days post first study treatment administration
The occurrence of DLT during the 'DLT reporting period' is defined as the period from study enrollment on D1 (Visit 1) up to 3 weeks after first pembrolizumab treatment on D73 (Visit 14).
The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15])
时间窗: Up to 94 days post first study treatment administration
The objective response rate (ORR) at the tumor assessment on Day 94 \[Visit 15\]), 6 weeks after the first pembrolizumab treatment administration.
次要结局
未报告次要终点