A Study of ALX148 With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer

计划状态

活跃,非招募

阶段

第二阶段

允许先接受免疫治疗

没有

CRC 指导的试验

药物

ALX148, cetuximab, Evorpacept (ALX148), Pembrolizumab, Erbitux, Keytruda

标签

MSS/ MMRp

评论

ALX148 + cetuximab + pembrolizumab for MSS patients who have received at least 2 lines of systemic therapy.
ALX148 (evorpacept): anti CD47, immunotherapy
Cetuximab: EGFR inhibitor (Erbitux)
Pembrolizumab: anti-PD1 checkpoint inhibitor, immunotherapy (Keytruda)

Left-sided RAS/BRAF Wild must have received EGFR inhibitor (cetuximab or panitumumab).

No prior checkpoint inhibitor (immunotherapy) allowed

有用链接

地点 位置状态
美国
University of Arizona Cancer Center
Tucson, Arizona 85724
活跃,非招募
科罗拉多大学癌症中心
科罗拉多州奥罗拉 80045
活跃,非招募
Rutgers Cancer insititute
新泽西州新不伦瑞克 08903
活跃,非招募
Inova Schar Cancer Institute
弗吉尼亚州费尔法克斯 22031
活跃,非招募

纳入标准

纳入标准

To be eligible to participate in this study, an individual must meet all of the following criteria:

* Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease
* Have microsatellite stable disease
* Adequate hematologic and end organ function

排除标准

排除标准:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Patients with known MSI-high status or known mismatch repair deficiency (dMMR)
* Patients in whom both mismatch repair and microsatellite stability status are unknown
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
* Left-sided (at or distal to the splenic flexure) RAS/BRAF wild-type metastatic colorectal cancer who are EGFR inhibitor naïve.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47, or anti-SIRPα agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)

NCT ID

NCT05167409

添加审判日期

2021-12-22

更新日期

2025-03-25