CTX-009 Treatment for Metastatic Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Metastatic Colorectal Cancer+2 MoreCTX-009 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: From C1D1 to death from any cause, average of 9 months

Month 7
Safety Profile of CTX-009
Month 9
Overall Survival
Month 6
Progression Free Survival
Month 6
Disease Control Rate
Exposure Response by Pharmacokinetic (PK) Sampling
Month 6
Overall Response Rate
Month 6
Duration of Response
Month 6
Quality of Life Changes

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

CTX-009 Treatment
1 of 1

Experimental Treatment

84 Total Participants · 1 Treatment Group

Primary Treatment: CTX-009 Treatment · No Placebo Group · Phase 2

CTX-009 Treatment
Drug
Experimental Group · 1 Intervention: CTX-009 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from c1d1 to death from any cause, average of 9 months

Who is running the clinical trial?

Compass TherapeuticsLead Sponsor
3 Previous Clinical Trials
399 Total Patients Enrolled
Thomas J Schuetz, MD, PhDStudy DirectorCompass Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically or cytologically confirmed metastatic or recurrent colorectal cancer.
You have a primary tumor that has been resected > 3 months prior to starting therapy with CTX-009.
You have at least one lesion measurable as defined by RECIST v1.1.
You have a performance status of 0 or 1.
You have a predicted life expectancy of at least 12 weeks.
You have an estimated creatinine clearance of 30 mL/min or greater.