What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as fluorouracil (FU), leucovorin (LV), oxaliplatin, and capecitabine, are associated with a range of side effects. FU and LV can cause diarrhea, nausea, vomiting, stomatitis, and neutropenia. Oxaliplatin is known for causing cumulative sensory neuropathy, which can persist long after treatment. Capecitabine, an oral prodrug of FU, often leads to hand-foot syndrome, diarrhea, nausea, and fatigue. These side effects can vary in severity and impact patients' quality of life, necessitating careful management and monitoring during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including chemotherapeutic agents like 5-fluorouracil (5-FU), oxaliplatin, and irinotecan. Targeted therapies such as bevacizumab, cetuximab, and panitumumab have also been approved, which work by inhibiting specific pathways involved in tumor growth and angiogenesis. Additionally, immunotherapies like pembrolizumab and nivolumab have been approved for use in certain cases of metastatic colorectal cancer, particularly those with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These treatments have provided various options for managing colorectal cancer, particularly in advanced stages.

What other types of research exist?

Promising novel alternatives to CTX-009 for colorectal cancer patients include: 1) Bevacizumab in combination with fluoropyrimidine-based chemotherapy (e.g., FOLFOX or XELOX), which has shown efficacy in first-line treatment of metastatic colorectal cancer. 2) Immunotherapy agents such as pembrolizumab, particularly for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. 3) Combination therapies involving targeted agents like cetuximab or panitumumab with chemotherapy for patients with RAS wild-type tumors. These alternatives have demonstrated significant clinical benefits in various studies and are considered effective options for colorectal cancer treatment.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 to death from any cause, average of 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Disease Control Rate

Duration of Response

Exposure Response by Pharmacokinetic (PK) Sampling

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CTX-009 TreatmentExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like oxaliplatin and irinotecan work by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted therapies, such as cetuximab and bevacizumab, inhibit specific molecules involved in cancer cell growth and blood vessel formation, respectively. Understanding these mechanisms helps patients and doctors choose the most effective treatment plan, manage side effects, and improve overall outcomes by tailoring therapy to the cancer's specific characteristics.

A Multidisciplinary Approach for the Personalised Non-Operative Management of Elderly and Frail Rectal Cancer Patients Unable to Undergo TME Surgery.Resection of hepatic metastases from colorectal cancer. Biologic perspective.