BXQ-350 for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorectal Cancer+1 MoreBXQ-350 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Colorectal Cancer
  • Neuropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: 6 months

6 months
CIPN Assessment
Disease Control Rate (DCR)
Duration of Response (DoR)
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
Objective Response Rate (ORR)
Overall Survival (OS)
Peak Plasma Concentration (Cmax)
Post Oxaliplatin Assessment
Progression Free Survival (PFS)
Recommended Phase 2 Dose
Total Sensory Neuropathy

Trial Safety

Trial Design

2 Treatment Groups

BXQ-350
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

195 Total Participants · 2 Treatment Groups

Primary Treatment: BXQ-350 · Has Placebo Group · Phase 1 & 2

BXQ-350
Drug
Experimental Group · 1 Intervention: BXQ-350 · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BXQ-350
2016
Completed Phase 1
~90

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

ICON plcIndustry Sponsor
63 Previous Clinical Trials
18,606 Total Patients Enrolled
Bexion Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
187 Total Patients Enrolled
Chief Scientific OfficerStudy DirectorBexion Pharmaceuticals, Inc.
6 Previous Clinical Trials
1,207 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have newly diagnosed Stage IV metastatic adenocarcinoma of the colon / rectum.
Creatinine clearance ≥ 50 mL/minute calculated using the Cockcroft-Gault formula (Cockcroft 1976): CCr = {((140 - age) x weight kg) / (72 x SCr)} x 0.
You have measurable disease at baseline based on RECIST 1.1 as determined by the local site Investigator / radiology assessment.
You are able to sit without assistance/restraint and control a wheelchair.