BXQ-350 for Colorectal Cancer

(ASIST Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BXQ-350 for individuals with newly diagnosed metastatic colon or rectal cancer. Researchers aim to determine if adding BXQ-350 to standard cancer treatments can enhance safety and effectiveness, and potentially reduce nerve damage caused by one of the standard drugs. Participants will receive either BXQ-350 or a placebo (a dummy treatment with no active drug), alongside usual cancer treatments. This trial suits those recently diagnosed with stage IV colon or rectal cancer who have visible tumors. As a Phase 1, Phase 2 trial, it focuses on understanding how BXQ-350 works in people and measuring its effectiveness in an initial, smaller group.

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.

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

Research has shown that BXQ-350 is safe and well-tolerated by patients in several studies. In these studies, patients received BXQ-350 at the highest planned doses without experiencing serious side effects. No dose-limiting toxicities occurred, meaning the treatment did not cause harmful effects that would prevent continuation.

One study found that BXQ-350 was safe for patients with advanced solid tumors and high-grade glioma, a type of brain cancer. Another study suggested that BXQ-350 might benefit patients with metastatic colorectal cancer and related nerve damage, with no major safety concerns reported.

Overall, these findings indicate that BXQ-350 is well-tolerated, making it a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BXQ-350 because it offers a novel approach to treating colorectal cancer. Unlike the standard chemotherapy or targeted therapies, BXQ-350 is administered through an IV infusion and is designed to potentially target cancer cells more precisely. This treatment uses a unique mechanism of action that could minimize damage to healthy cells and possibly reduce side effects. By offering a new way to tackle cancer, BXQ-350 could provide hope for more effective and less toxic treatment options for patients with colorectal cancer.

What evidence suggests that BXQ-350 could be an effective treatment for colorectal cancer?

Research has shown that BXQ-350, which participants in this trial may receive, may help treat advanced colorectal cancer. In one study, eight patients experienced stable cancer for at least six months, meaning it did not worsen. Two of these patients even saw their tumors shrink. BXQ-350 is also designed to help with nerve damage, a common side effect of cancer treatment. Patients have tolerated the treatment well, with some continuing it for over a year. These findings suggest BXQ-350 could be a helpful addition to current cancer treatments. ^{2 3 4 5 6}

Who Is on the Research Team?

Chief Scientific Officer

Principal Investigator

Bexion Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. targetedonc.com targetedonc.com/view/phase-1b-2-study-of-bxq-350-in-metastatic-colorectal-cancer-completes-enrollment

Phase 1b/2 Study of BXQ-350 in Metastatic Colorectal ... "BXQ-350's mechanism of action lends itself to potential benefit in [patients with] metastatic colorectal [cancer] and peripheral neuropathy.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.TPS224

BXQ-350: A phase 1b/2 placebo controlled, double blinded ... Primary objectives of the Phase 1b are to assess safety, identify RP2D, and assess preliminary efficacy of BXQ-350 in this combination.

3. onclive.com onclive.com/view/bxq-350-is-well-tolerated-shows-clinical-activity-in-advanced-solid-tumors

BXQ-350 Is Well Tolerated, Shows Clinical Activity in ... Regarding efficacy, 8 patients achieved a progression-free survival (PFS) of at least 6 months. Two of these patients experienced a partial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05322590

NCT05322590 | BXQ-350 in Newly Diagnosed Metastatic ... The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed ...

5. bexionpharma.com bexionpharma.com/wp-content/uploads/2025/03/BXQ-350-AA-Manuscript_2024_11_04.pdf

A First-in-Human Phase I Study of BXQ-350, a ... Of those with progression-free survival of ≥6 months, seven remained on study for >12 months, five for >24 months, and after 7 years, two remained on study ...

6. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.e14044

A phase 1 study to evaluate the safety and tolerability of ... Results: BXQ-350 has shown safety and tolerability in both adult and pediatric Phase 1 studies, reaching the highest planned dose without any ...