NCT05513742

A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer

A Phase 2 Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer Who Have Received Two or Three Prior Systemic Chemotherapy Regimens

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Compass Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer. A Simon Two-Stage adaptive design will enroll approximately 37 patients into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled.

Conditions

• Metastatic Colorectal Cancer
• Colon Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	CTX-009	IV infusion administered on day 1 and 15 of every 28-day cycle

Timeline

• Start date: 2022-12-08
• Primary completion: 2025-04-28
• Completion: 2025-05-15
• First posted: 2022-08-24
• Last updated: 2026-04-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study