COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC.

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) Tweetable Abstract 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 Article highlights Most patients with biliary tract cancer (BTC) receive diagnoses at an advanced stage of the disease when prognoses are poor. Given the limited survival benefit observed with current therapies, there remains a need for novel therapeutic regimens to treat patients with advanced BTC in the second-line setting after failure of front-line regimens. Background & rationale CTX-009 combined with paclitaxel has shown clinical benefit with manageable toxicity in patients with advanced BTC. The combination of CTX-009 and paclitaxel could be beneficial for patients with BTC as a second-line therapy for advanced disease. COMPANION-002 study design & eligibility criteria COMPANION-002 is a multicenter, randomized, phase II/III study evaluating the efficacy and safety of CTX-009 in combination with paclitaxel as second-line treatment for patients with advanced or metastatic BTC. Eligible patients with a histologically or cytologically confirmed diagnosis of previously treated, locally advanced unresectable or metastatic BTC will be randomly assigned to receive CTX-009 in combination with paclitaxel or paclitaxel alone in a 2:1 ratio. Outcome measures/end points The primary end point is overall response rate. Secondary end points are progression free survival and overall survival. Conclusion The CTX-009 study will further define the role of CTX-009 in patients with advanced BTC. [ABSTRACT FROM AUTHOR]