NCT05506943

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

A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Compass Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Cancer
• Cholangiocarcinoma
• Gall Bladder Cancer
• Ampullary Cancer

Interventions

Type	Name	Description
DRUG	CTX-009	IV infusion on day 1 and 14 of every 28 day cycle
DRUG	Paclitaxel	IV infusion on day 1, 8, and 15 of every 28 day cycle

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2022-08-18
• Last updated: 2025-04-20

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study