QBECO for Colorectal Cancer with Liver Metastases

(PERIOP-06 Trial)

Recruiting at 3 trial locations

Overseen By Ellen Green

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Extrahepatic metastases, Invasive cancer, Autoimmune, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

115 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a drug called QBECO can prevent colorectal cancer from spreading, especially to the liver. Made from inactive E. coli bacteria, QBECO aims to boost the immune system before and after surgery to remove liver cancer. Participants will self-inject QBECO for a set period around their surgery. Individuals diagnosed with colorectal cancer with liver metastases, who plan to undergo surgery to remove visible cancer, might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic steroids or immunosuppressive drugs, you may need to stop them before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that QBECO is generally well-tolerated. Safety data from 208 participants indicated it was safe. Additionally, other studies found it did not cause serious harm, demonstrating a wide safety margin.

The treatment uses inactivated E. coli bacteria to address issues in the digestive system and related organs, such as the liver. Researchers have tested this method to see if it can help the immune system recover after surgery. While these results are promising, discussing any concerns or questions with the study team or your doctor is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colorectal cancer with liver metastases, which often rely on chemotherapy and surgery, QBECO is unique because it uses an innovative approach to boost the immune system. This investigational treatment is derived from inactivated E. coli bacteria, formulated to specifically target the gastrointestinal tract and related organs like the liver. Researchers are excited about QBECO because it aims to reduce postoperative immune suppression and improve progression-free survival, potentially providing a more effective and targeted therapy compared to current options.

What evidence suggests that QBECO might be an effective treatment for colorectal cancer with liver metastases?

This trial will compare QBECO with a placebo in treating colorectal cancer that has spread to the liver. Research has shown that QBECO might help treat this condition. In animal studies, QBECO significantly reduced cancer spread to the liver, suggesting it can strengthen the body's immune system to fight cancer in the liver and gut. Early clinical data indicates it is safe and may improve recovery after surgery. Overall, the initial results are promising, but more research in humans is needed to confirm its effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Paul Karanicolas

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

Adults with colorectal cancer that has spread to the liver, who are planning surgery for it and can self-inject or have someone to inject a study medication. They must not be pregnant, nursing, have other cancers within 5 years (except certain skin cancers), severe autoimmune diseases requiring steroids or immunosuppressants, or active HIV/Hepatitis B/C.

Inclusion Criteria

I will finish my pre-surgery chemotherapy 25 days before my surgery.

I've had a CT scan with contrast of my chest, abdomen, and pelvis within the last 6 weeks.

Agree to comply with the contraceptive requirements of the protocol when applicable

Exclusion Criteria

I have had no cancer other than colorectal in the last 5 years, except for skin cancers or in situ cancers.

My cancer has spread beyond the liver, but I might have small lung nodules.

Pregnant patients or those who are nursing an infant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants self-inject QBECO or placebo every two days for 11-120 days before surgery

11-120 days

Postoperative Treatment

Participants continue to self-inject QBECO or placebo every two days for 41 days after surgery

41 days

Follow-up

Participants are monitored for safety and effectiveness every 3 months for 2 years, with a final visit at year 5

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• QBECO

Trial Overview The trial is testing QBECO injections against a placebo in patients with metastatic colorectal cancer to the liver. Participants will self-inject QBECO or placebo before and after their surgery for at least 11 days pre-surgery and 41 days post-surgery. The study aims to see if this treatment prevents cancer progression better than current standard care.

How Is the Trial Designed?

Group I: QBECO Experimental Treatment 1 Intervention

QBECO is an SSI formulated from inactivated E. coli bacteria that is specifically designed to target pathologies of the gastrointestinal (GI) tract and related organs, such as the liver. This trial will test the hypothesis that in patients undergoing resection of colorectal liver metastases (CRLMs), perioperative treatment with QBECO will attenuate the postoperative immune suppression and will improve progression-free survival (PFS).

Group II: Placebo Placebo Group 1 Intervention

A placebo is a liquid that looks like the study drug, but contains no medication.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05677113

NCT05677113 | A Study of QBECO Versus Placebo in the ... QBECO is a site specific immunomodulator (SSI) designed to promote innate immune responses in the gastrointestinal tract and related organs, including the liver ...

2. trial.medpath.com trial.medpath.com/clinical-trial/0b3533e09b38812f

A Study of QBECO Versus Placebo in the Treatment of Colorectal ... This trial is motivated by the promising preclinical and clinical data supporting the safety and efficacy of QBECO in attenuating postoperative ...

3. qubiologics.com qubiologics.com/qu-biologics-and-foundation-medicine-collaborate-to-impact-the-care-of-patients-with-late-stage-colorectal-cancer/

Qu Biologics and Foundation Medicine Collaborate to ... Qu Biologics is currently enrolling patients with late-stage colorectal cancer undergoing surgical resection of liver metastases in a randomized ...

4. firstwordpharma.com firstwordpharma.com/story/5656520

Qu Biologics to Launch Phase 2B Clinical Trial to Assess ... This trial will assess whether perioperative QBECO SSI treatment can serve as a unique multi-pronged approach to transform outcomes for cancer patients ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/13/NCT05677113/Prot_SAP_000.pdf

4.0 dated 19.AUG.2024 In a murine model of metastatic colorectal cancer (MC38 in C57BL/6 mice), perioperative. QBECO resulted in a significant reduction in hepatic ...

6. qubiologics.com qubiologics.com/periop-06-study/

PERIOP-06 Study QBECO is an SSI designed to restore innate immune responses in the gastrointestinal tract and related organs, including the liver. This trial is motivated by ...

7. qubiologics.com qubiologics.com/what-we-do/ssi-platform/

SSI Platform A Phase 2 randomized, placebo-controlled, double-blind study (PERIOP-06 study) assessing the effectiveness of QBECO SSI to prevent postoperative immune ...