BXQ-350 for Colorectal Cancer

(ASIST Trial)

Recruiting at 14 trial locations

Overseen By Bexion Pharmaceuticals, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bexion Pharmaceuticals, Inc.

Must be taking: mFOLFOX7, Bevacizumab

Must not be taking: Neurotoxic chemotherapy, Anti-VEGF, Neuropathy agents

Disqualifiers: Diabetes, Hypertension, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

195 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish oxaliplatin induced sensory neurotoxicity, enabling participants to receive the total and planned doses of mFOLFOX7. All participants will receive BXQ-350 by intravenous (IV) infusion along with standard of care doses of mFOLFOX and bevacizumab. The study is divided into two stages: Stage 1 will be open label and will enroll participants at increasing dose levels of BXQ-350 in order to determine the Stage 2 dose. Stage 2 will be blinded; participants will receive BXQ-350 at the established Stage 1 dose or placebo.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently taking medications for peripheral neuropathy or have received certain neurotoxic chemotherapies or anti-VEGF agents before.

What data supports the effectiveness of the drug BXQ-350 for colorectal cancer?

BXQ-350 has shown antitumor effects in preclinical studies and clinical activity in adult patients with recurrent high-grade gliomas, which suggests it might have potential benefits for other types of tumors, including colorectal cancer. ^{1 2 3 4 5}

Is BXQ-350 safe for humans?

BXQ-350 has been studied for safety in children and young adults with relapsed solid tumors, including brain tumors, and has shown preclinical antitumor effects. However, specific safety data for colorectal cancer is not available from the provided research. ^{1 2 5 6 7}

What makes the drug BXQ-350 unique for colorectal cancer treatment?

BXQ-350 is unique because it is a new type of cancer treatment that uses a combination of saposin C (a protein) and a phospholipid (a type of fat) to target and kill cancer cells by binding to a specific part of the cell surface, which is different from traditional chemotherapy methods. ^{1 2 3 5 8}

Research Team

Chief Scientific Officer

Principal Investigator

Bexion Pharmaceuticals, Inc.

Eligibility Criteria

Adults over 18 with newly diagnosed Stage IV metastatic adenocarcinoma of the colon/rectum, measurable disease, life expectancy >3 months, and good performance status. They must have proper organ function and agree to use effective contraception. Excluded are those with certain other cancers, diabetes, specific heart conditions, uncontrolled infections or prior treatments that could interfere.

Inclusion Criteria

My kidney function is good, with acceptable creatinine clearance and protein levels.

Measurable disease at baseline based on RECIST 1.1

Life expectancy > 3 months

Exclusion Criteria

Breastfeeding or pregnant

My family has a history of genetic nerve disorders.

I have had another cancer in the last 5 years that could shorten my life.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Stage 1

Open-label phase where participants receive BXQ-350 at increasing dose levels to determine the Stage 2 dose

6 months

Regular visits for dose escalation and monitoring

Treatment - Stage 2

Blinded phase where participants receive BXQ-350 at the established Stage 1 dose or placebo

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• BXQ-350
• Placebo

Trial Overview The trial is testing BXQ-350 combined with mFOLFOX7 chemotherapy and bevacizumab against a placebo combination in patients with colorectal cancer. The first stage determines the safe dose of BXQ-350; the second stage tests its effectiveness at that dose compared to placebo.

Participant Groups

Group I: BXQ-350 Experimental Treatment 1 Intervention

BXQ-350 will be administered by IV infusion

Group II: Placebo Placebo Group 1 Intervention

Placebo (0.9% normal saline) will be administered by IV infusion (Stage 2 only)

Who Is Running the Clinical Trial?

Bexion Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

330+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

CTI Clinical Trial and Consulting Services

Collaborator

Trials

36

Recruited

3,700+

Findings from Research

In a study of 44 post-operative colorectal cancer patients, Quxie Capsule (QXC) showed potential in improving quality of life and immune function, with significant improvements in symptoms and Karnofsky Performance Status (KPS) scores compared to placebo.

While QXC did not significantly reduce the relapse-metastasis (R-M) rate or median time to R-M compared to placebo, it was found to be safe with no obvious adverse reactions, suggesting it may have clinical significance in post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical randomized double-blinded controlled study on Quxie Capsule in reducing post-operational relapse and metastasis of colorectal cancer]. Yang, YF., Xu, Y., Wu, Y.[2016]

In a randomized, double-blind, placebo-controlled trial involving 60 patients with metastatic colorectal cancer, the Quxie Capsule combined with conventional therapies significantly improved overall survival (OS) to a median of 23.9 months compared to 14.3 months in the control group.

While there was no significant difference in progression-free survival (PFS) between the two groups, certain subgroups (like those receiving second-line therapy and with left-sided colon cancer) showed notable survival benefits from the Quxie Capsule, indicating its potential effectiveness in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Quxie Capsule in Metastatic Colorectal Cancer: Long-Term Survival Update of A Double-Blind, Randomized, Placebo Controlled Trial. Zhang, T., Xu, Y., Sun, LY., et al.[2022]

In a study of 18 patients with wild-type K-RAS metastatic colorectal cancer, the bi-weekly combination of SOX (S-1 and oxaliplatin) with cetuximab showed a promising response rate of 67%, with 2 complete responses and 10 partial responses, indicating effective treatment.

The treatment was well-tolerated, with only 28% of patients experiencing serious adverse events, which were manageable through dose adjustments and preventive care, suggesting that this regimen can be safely administered without requiring treatment withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Report of Phase II Study on Bi-weekly SOX plus Cetuximab Treatment for Wild-type K-RAS Advanced and Recurrent Colorectal Cancer. Ogawa, M., Anan, T., Suzuki, T., et al.[2018]

In a randomized controlled trial involving 40 patients with advanced colorectal carcinoma, the addition of Quxie Capsule (QXC) to standard cancer treatments significantly improved median survival time (17 months in the treatment group vs. 13 months in the control group) and reduced the fatality rate (11.1% in the treatment group vs. 42.1% in the control group).

Patients taking QXC also experienced significant improvements in quality of life and symptom scores after treatment, while those in the control group showed a worsening in these measures, indicating that QXC not only extends survival but also enhances the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Randomized controlled study on effect of Quxie capsule on the median survival time and qualify of life in patients with advanced colorectal carcinoma]. Yang, YF., Chen, ZX., Xu, Y.[2016]

In a randomized trial with 60 patients suffering from metastatic colorectal cancer, the Quxie Capsule combined with conventional therapy showed a trend towards improved overall survival (OS) of 23 months compared to 14 months in the placebo group, particularly benefiting younger patients and those receiving second-line therapy.

The study demonstrated that Quxie Capsule is safe, with no severe side effects reported, indicating it could be a beneficial addition to treatment regimens for metastatic colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Quxie Capsule () in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial. Zhang, T., Yang, YF., He, B., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

An open-label multi-center phase 1 safety study of BXQ-350 in children and young adults with relapsed solid tumors, including recurrent malignant brain tumors. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Clinical randomized double-blinded controlled study on Quxie Capsule in reducing post-operational relapse and metastasis of colorectal cancer]. [2016]

3. China pubmed.ncbi.nlm.nih.gov

Efficacy of Quxie Capsule in Metastatic Colorectal Cancer: Long-Term Survival Update of A Double-Blind, Randomized, Placebo Controlled Trial. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Initial Report of Phase II Study on Bi-weekly SOX plus Cetuximab Treatment for Wild-type K-RAS Advanced and Recurrent Colorectal Cancer. [2018]

5. China pubmed.ncbi.nlm.nih.gov

[Randomized controlled study on effect of Quxie capsule on the median survival time and qualify of life in patients with advanced colorectal carcinoma]. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Serious Adverse Events Reporting in Phase III Randomized Clinical Trials of Colorectal Cancer Treatments: A Systematic Analysis. [2021]

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

A multicenter phase 1 study of PX-866 and cetuximab in patients with metastatic colorectal carcinoma or recurrent/metastatic squamous cell carcinoma of the head and neck. [2022]

8. China pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Quxie Capsule () in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial. [2018]