1. COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC.
- Author
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Azad, Nilofer, Hu, Zishuo, Sahin, Ilyas, Iyer, Renuka, Aranha, Olivia, Hochster, Howard, Pathak, Priyadarshini, Paulson, Andrew, Kalyan, Aparna, Liao, Chih-Yi, Tran, Nguyen, Kelley, Robin, Heestand, Gregory, Cosgrove, David, El-Khoueiry, Anthony, Borad, Mitesh, Gabrail, Nashat, Majeed, Umair, Du, Lingling, Kamath, Suneel, Shumway, Nathan, Shroff, Rachna, Goyal, Lipika, Rosales, Minori, and Javle, Milind
- Subjects
CTX-009 ,DLL4 ,Paclitaxel ,VEGF ,anti-angiogenesis ,biliary tract cancer ,cholangiocarcinoma ,clinical trial ,Humans ,Paclitaxel ,Antineoplastic Combined Chemotherapy Protocols ,Biliary Tract Neoplasms ,Male ,Female ,Middle Aged ,Antibodies ,Bispecific ,Aged ,Adult ,Vascular Endothelial Growth Factor A ,Treatment Outcome - 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).
- Published
- 2024
