Abstract：
Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as both a monotherapy and in combination with chemotherapy. In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% overall response rate (ORR). Described here is the design of and rationale for COMPANION-002, a randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line treatment for patients with advanced biliary tract cancer. The primary end point is ORR, and crossover is allowed.Clinical Trial Registration: NCT05506943 (ClinicalTrials.gov).
Looking for new options for patients with advanced biliary tract cancer? Explore COMPANION-002, Compass Therapeutics’ phase II/III study of CTX-009 + paclitaxel as a second line treatment.#CMPX #biotech #healthcare #rarecancer.
Looking for new options for patients with advanced biliary tract cancer? Explore COMPANION-002, Compass Therapeutics’ phase II/III study of CTX-009 + paclitaxel as a second line treatment.#CMPX #biotech #healthcare #rarecancer.
摘要：
胆道癌患者的治疗选择有限，预后较差。CTX-009，一种靶向DLL4和VEGF-A的新型双特异性抗体，作为单一疗法和联合化疗，已在晚期癌症患者中显示出抗肿瘤活性。在接受过一种或两种先前疗法的晚期胆道癌患者的II期研究中，使用紫杉醇的CTX-009表现出37.5%的总应答率(ORR)。这里描述的是COMPANION-002的设计和基本原理，这是一项随机的II/III期研究，这将评估CTX-009联合紫杉醇与单独紫杉醇作为晚期胆道癌患者二线治疗的安全性和有效性。主要终点是ORR,和交叉是允许的。临床试验注册：NCT05506943（ClinicalTrials.gov）。
寻找晚期胆道癌患者的新选择吗？探索COMPANION-002，CompassTherapeutics的CTX-009+紫杉醇作为二线治疗的II/III期研究。#CMPX#生物技术#医疗保健#rrecancer。
寻找晚期胆道癌患者的新选择吗？探索COMPANION-002，CompassTherapeutics的CTX-009+紫杉醇作为二线治疗的II/III期研究。#CMPX#生物技术#医疗保健#rrecancer。
