Press release
Compass Therapeutics Completes Patient Enrollment in COMPANION-002, a Randomized Study of CTX-009 in Combination with Paclitaxel, and Provides an Update on the Development Plan in Biliary Tract Cancer
Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel versus paclitaxel in patients with previously
About this update from Compass Therapeutics, Inc.
[{"type":"text","content":"Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced Metastatic or Recurrent Biliary Tract Cancers (BTC) Approved an Investigator Sponsored Trial (IST) of CTX-009 in the first-line setting in patients with Biliary Tract Cancer BOSTON, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that it completed enrollment of the planned 150 patients in COMPANION-002, its randomized Phase 2/3 clinical trial of CTX-009 in patients with BTC. “We are very pleased to announce this enrollment milestone for the COMPANION-002 trial. We extend our deep gratitude to all the patients, families, and caregivers who are participating in the study. We would also like to thank the principal investigators, study coordinators, the Cholangiocarcinoma Foundation, and the clinical team at Compass for their dedicated support and hard work.” said Thomas Schuetz, MD, PhD, Co-founder, CEO, and Vice Chairman of the Compass Board of Directors. Importantly, the Company also announced the approval of a new IST for the study of CTX-009 in patients with BTC who will be treated in the first-line setting. The trial will be conducted at The University of Texas MD Anderson Cancer Center. CTX-009 will be added to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab. “Following completion of enrollment in COMPANION-002, our second-line study, we are very excited to advance CTX-009 to the first-line setting in collaboration with our investigators at MD Anderson,” added Dr. Schuetz. About COMPANION-002 The COMPANION-002 study (NCT05506943) is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel alone in patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen. The trial is designed to enroll 150 patients with a primary endpoint of overall response rate (ORR) and secondary endpoints that include progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR), and du...