A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

计划状态

活跃,非招募

阶段

第 1 阶段

允许先接受免疫治疗

没有

CRC 指导的试验

没有

药物

5-FU + Cisplatin, Evorpacept (ALX148), Pembrolizumab, Ramucirumab + Paclitaxel, Rituximab, Trastuzumab

标签

MSS/ MMRp

评论

Phase 1 protocol will have 2 parts: a single agent dose escalation phase (Part 1) and a combination therapy phase (Part 2), with Pembrolizumab, Trastuzumab, or Rituximab .
Part 2 will include an initial dose escalation portion followed by a dose expansion portion.

CD47/SIRPa-blocking agent ALX148

Potential phagocytosis-inducing, immunostimulating and antineoplastic activities. Upon administration, ALX148 binds to CD47 expressed on tumor cells and prevents the interaction of CD47 with its ligand SIRPa, a protein expressed on phagocytic cells. This prevents CD47/SIRPa-mediated signaling and abrogates the CD47/SIRPa-mediated inhibition of phagocytosis. This induces pro-phagocytic signaling mediated by the binding of the pro-phagocytic signaling protein calreticulin (CRT), which is specifically expressed on the surface of tumor cells, to low-density lipoprotein (LDL) receptor-related protein (LRP), expressed on macrophages. This results in macrophage activation and the specific phagocytosis of tumor cells. In addition, blocking CD47 signaling activates both an anti-tumor cytotoxic T-lymphocyte (CTL) immune response and T-cell-mediated killing of CD47-expressing tumor cells. CD47, also called integrin-associated protein (IAP), is a tumor-associated antigen (TAA) expressed on normal, healthy hematopoietic stem cells (HSC) and overexpressed on the surface of a variety of cancer cells. Expression of CD47, and its interaction with SIRPa, leads to the inhibition of macrophage activation and protects cancer cells from phagocytosis, which allows cancer cells to proliferate.

地点 位置状态
美国
University of Colorado Denver
科罗拉多州丹佛 80045
活跃,非招募
耶鲁大学
康涅狄格州纽黑文 06520
活跃,非招募
麻省总医院
马萨诸塞州波士顿 02114
活跃,非招募
达纳法伯癌症研究所
马萨诸塞州波士顿 02215
活跃,非招募
START-Midwest
Grand Rapids, Michigan 49503
活跃,非招募
Seattle Cancer Care Alliance
华盛顿州西雅图 98109
活跃,非招募
大韩民国
Seoul National University Bundang Hospital
Seongnam
活跃,非招募
三星医疗中心
Seoul
活跃,非招募
首尔大学医院
Seoul
活跃,非招募
Severance Hospital, Yonsei University
Seoul
活跃,非招募

纳入标准

纳入标准

Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy; or relapsed or refractory Non-Hodgkin lymphoma for whom no standard therapy is available..
Adequate Bone Marrow Function.
Adequate Renal & Liver Function.
Adequate Performance Status

排除标准

排除标准:

Patients with known symptomatic CNS metastases or lepotomeningeal disease requiring steroids.
Previous high-dose chemotherapy requiring allogenic stem cell rescue.
Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting agent.

NCT ID

NCT03013218

添加审判日期

2017-01-06

更新日期

2024-03-22