CTX-009 for Colon Cancer

(COMPANION-003 Trial)

Recruiting at 7 trial locations

Overseen By Karin Herrara

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Compass Therapeutics

Must not be taking: Antiplatelets, Anticoagulants, NSAIDs, Corticosteroids

Disqualifiers: Cardiovascular diseases, CNS metastasis, Hemorrhage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

84 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called CTX-009 in patients whose colorectal cancer has spread. The goal is to see if it can shrink the tumors or stop them from growing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot take antiplatelet or anticoagulant drugs within 2 weeks before starting the trial, and continuous use of certain other medications like NSAIDs or systemic corticosteroids is restricted. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug CTX-009 for colon cancer?

Research on cetuximab (CTX), a component of CTX-009, shows it has been used in combination with other treatments for advanced colorectal cancer, although its effectiveness can vary based on patient factors like age and health conditions. ^{1 2 3 4 5}

Research Team

Minori Rosales, MD, PhD

Principal Investigator

Compass Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

Patients must have signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed

I am a woman who can have children and have a negative pregnancy test.

My primary tumor was removed over 3 months ago.

Exclusion Criteria

I had chemotherapy or targeted therapy for colorectal cancer less than 4 weeks ago.

I have brain metastases that are causing symptoms or are not under control.

Patients with other severe diseases or uncontrolled illnesses that warrant the exclusion from the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CTX-009 in an open-label, adaptive Simon Two-Stage study

6 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Follow-up visits as per study protocol

Treatment Details

Interventions

• CTX-009

Trial Overview 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.

Participant Groups

Group I: CTX-009 Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Compass Therapeutics

Lead Sponsor

Trials

5

Recruited

430+

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase II study evaluating the addition of cetuximab to the concurrent delivery of weekly carboplatin, paclitaxel, and daily radiotherapy for patients with locally advanced squamous cell carcinomas of the head and neck. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patterns of progression, treatment of progressive disease and post-progression survival in the New EPOC study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Comorbidity, age and overall survival in cetuximab-treated patients with advanced colorectal cancer (ACRC)--results from NCIC CTG CO.17: a phase III trial of cetuximab versus best supportive care. [2020]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The possibilities to improve the outcomes in patients with colon cancer complicated by acute obstruction]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The use of neo-adjuvant chemotherapy in patients with resectable colorectal liver metastases: Clinical risk score as possible discriminator. [2018]