A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)

Phase 2/3 Active not recruiting 168 enrolled Compass Therapeutics

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.

Timeline

Start: 2023-01-09
Primary completion: 2027-08-31
Completion: 2027-08-31

Outcome

Met primary endpoint

release “positive primary endpoint data from the COMPANION-002 study of tovecimig in patients with advanced biliary tract cancer” compasstherapeutics.com ↗

Publications

Azad N, Hu Z, Sahin I, Iyer R, Aranha O, Hochster H, Pathak P, Paulson AS, Kalyan A, Liao CY, Tran N, Kelley RK, Heestand G, Cosgrove D, El-Khoueiry A, Borad M, Gabrail NY, Majeed U, Du L, Kamath S, Shumway N, Shroff R, Goyal L, Rosales M, Javle M. COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC. Future Oncol. 2024;20(30):2241-2248. doi: 10.1080/14796694.2024.2351351. Epub 2024 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CTX-009	Unknown	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous