Future oncology (London, England) · 2024
COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Azad Nilofer, Hu Zishuo, Sahin Ilyas, Iyer Renuka, Aranha Olivia, Hochster Howard, Pathak Priyadarshini, Paulson Andrew Scott, Kalyan Aparna, Liao Chih-Yi, Tran Nguyen, Kelley Robin K, Heestand Gregory, Cosgrove David, El-Khoueiry Anthony, Borad Mitesh, Gabrail Nashat Y, Majeed Umair, Du Lingling, Kamath Suneel, Shumway Nathan, Shroff Rachna, Goyal Lipika, Rosales Minori, Javle Milind
Аннотация
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).