CTX-009 for Colon Cancer

(COMPANION-003 Trial)

No longer recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CTX-009 for individuals with colon cancer that has spread to other parts of the body. The goal is to determine how effectively CTX-009 stops or slows the cancer's growth. It seeks participants who had their tumor surgically removed more than three months ago and whose cancer progressed after two or three other treatments. This study may suit those who have tried treatments like chemotherapy and still have a measurable tumor. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

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.

Is there any evidence suggesting that CTX-009 is likely to be safe for humans?

Research shows that CTX-009, a new treatment under study for colon cancer, has shown promising results in early trials. In some cases, researchers tested CTX-009 alone and with another drug called paclitaxel. These studies found that patients generally tolerated the treatment well. The side effects were similar to those seen in earlier research, meaning they were expected and not unusually severe.

Previous patients treated with CTX-009 demonstrated that it can help shrink tumors. While all treatments can have side effects, CTX-009 hasn't shown any new safety concerns in the studies so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colon cancer, which often include chemotherapy, radiation, and targeted therapies like bevacizumab and cetuximab, CTX-009 offers a fresh approach. Researchers are excited about CTX-009 because it uses a novel mechanism of action, potentially targeting cancer cells more effectively than current options. This could lead to better outcomes for patients, particularly those who have not responded well to existing treatments. Additionally, CTX-009 might offer fewer side effects, making it a promising candidate for improving the quality of life for those undergoing treatment.

What evidence suggests that CTX-009 might be an effective treatment for colon cancer?

Research has shown that CTX-009, a new treatment for advanced colorectal cancer, may help shrink tumors. In earlier studies, patients who received CTX-009 responded well, even when other treatments no longer worked. CTX-009 is a bispecific antibody, targeting two proteins, DLL4 and VEGF-A, to help stop tumor growth. This dual action is believed to contribute to its effectiveness against advanced cancers. The treatment has already demonstrated its ability to fight tumors in patients with various advanced cancers, suggesting it could also be effective for colorectal cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Minori Rosales, MD, PhD

Principal Investigator

Compass Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: CTX-009 Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Compass Therapeutics

Lead Sponsor

Trials

5

Recruited

430+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05513742

NCT05513742 | A Study of CTX-009 in Adult Patients With ... 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.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.TPS281

Trial in progress: A phase 2 study of CTX-009 in adult ... In a Phase 1 study with CTX-009, responses have been seen in patients with colorectal cancers who were treated in the 4th line setting. Since ...

3. withpower.com withpower.com/trial/phase-2-metastatic-colorectal-cancer-crc-10-2022-89308

CTX-009 for Colon Cancer (COMPANION-003 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11509068/

COMPANION-002 A clinical trial of investigational drug CTX ... CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as both a monotherapy ...

5. ainvest.com ainvest.com/news/compass-therapeutics-completes-phase-2-study-ctx-009-metastatic-colorectal-cancer-treatment-2506/

Compass Therapeutics Completes Phase 2 Study on CTX ... The trial, which was conducted to assess the effectiveness of CTX-009 in patients with advanced colorectal cancer, showed promising results.

6. investors.compasstherapeutics.com investors.compasstherapeutics.com/news-releases/news-release-details/compass-therapeutics-announces-phase-2-data-ctx-009-combination

News Release Details As the data continue to mature, safety and tolerability of CTX-009 in combination with paclitaxel remain consistent with previous studies.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05506943

A Study of CTX-009 in Combination With Paclitaxel in Adult ... 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 ...