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CTX-009 for Colon Cancer (COMPANION-003 Trial)
Phase 2
Waitlist Available
Research Sponsored by Compass Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from c1d1 to death from any cause, average of 9 months
Awards & highlights
COMPANION-003 Trial Summary
This trial studies a potential new treatment for metastatic colorectal cancer, enrolling up to 84 patients. Results may provide better care for those with the disease.
Who is the study for?
Adults over 18 with metastatic colorectal cancer that's been previously treated with specific chemotherapy regimens. They must have measurable cancer lesions, adequate liver and kidney function, and no severe heart or blood pressure issues. Women of childbearing potential and men must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing CTX-009 in patients with advanced colorectal cancer using an open-label, adaptive two-stage design. Stage one will enroll about 37 patients; if successful, stage two will add another 47 patients to assess the drug's effectiveness.See study design
What are the potential side effects?
While not explicitly listed here, common side effects for cancer treatments like CTX-009 may include nausea, fatigue, increased risk of infection due to lowered immunity, possible liver or kidney function changes, and reactions at the infusion site.
COMPANION-003 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from c1d1 to death from any cause, average of 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 to death from any cause, average of 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Exposure Response by Pharmacokinetic (PK) Sampling
+4 moreCOMPANION-003 Trial Design
1Treatment groups
Experimental Treatment
Group I: CTX-009 TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Compass TherapeuticsLead Sponsor
4 Previous Clinical Trials
454 Total Patients Enrolled
Thomas J Schuetz, MD, PhDStudy DirectorCompass Therapeutics
Minori Rosales, MD, PhDStudy DirectorCompass Therapeutics
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had chemotherapy or targeted therapy for colorectal cancer less than 4 weeks ago.I am a woman who can have children and have a negative pregnancy test.I have brain metastases that are causing symptoms or are not under control.I am 18 years old or older.My primary tumor was removed over 3 months ago.My cancer has worsened after 2 or 3 treatments for advanced stages.I have received all approved targeted therapies for my tumor's specific mutations.I have had heart problems in the last 5 years.I had radiation therapy less than 2 weeks ago.I do not have a severe infection needing strong antibiotics or have any uncontrolled infectious diseases.My liver and kidney functions are within normal ranges.I can carry out all my usual activities without help.I am following the required birth control guidelines.My colorectal cancer has spread or come back.I haven't taken certain medications recently.I had surgery or a major procedure less than 4 weeks ago.I haven't had cancer immunotherapy or experimental drugs in the last 4 weeks.My left-sided tumor is RAS wild type and I've had anti-EGFR therapy.I have a history of bleeding or stomach-related diseases.My previous treatments included specific chemotherapy drugs.
Research Study Groups:
This trial has the following groups:- Group 1: CTX-009 Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being included in this research trial?
"Affirmatively, the information on clinicaltrials.gov reveals that this research is presently enrolling participants. The trial was first publicized on December 8th 2022 and has been updated since then. 84 individuals are being sought out from a single medical facility."
Answered by AI
Is this medical experiment still accepting participants?
"Affirmative. The information available on clinicaltrials.gov attests that this medicinal experiment, which was initially published on December 8th 2022, is currently enrolling participants. Approximately 84 individuals must be enrolled from a single medical establishment."
Answered by AI
What data exists regarding the safety of CTX-009 for patients?
"Through the Power evaluation, CTX-009 Treatment achieved a rating of 2 due to its Phase 2 status and existing safety records but lack of efficacy data."
Answered by AI
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