BXQ-350 for Colorectal Cancer

(ASIST Trial)

Recruiting at14 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Bexion Pharmaceuticals, Inc.

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.

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.

Treatment Details

Interventions

• BXQ-350 (Other)
• Placebo (Other)

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+