BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a cell membrane phospholipid (clinical formulation BXQ-350).Due to the presumed mechanism of action of BXQ-350, Bexion anticipates that it may have an impact on ceramides, sphingosine-1-phosphate (S1P), and inflammatory cytokine levels. In addition, pre-clinical results demonstrated that BXQ-350 induced neurite generation and protection in vitro in the PC-12 and NS20Y cell lines and significantly decreased oxaliplatin-induced cold allodynia in a model of CIPN. Thus BXQ-350 may represent a new approach to deliver a neuropathy benefit. The unique combination of BXQ-350 along with its proven safety profile, potential efficacy, and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to use in combination with standard of care treatment for mCRC to not only enhance the standard treatment of mCRC, but also to evaluate its ability to alleviate side effects related to oxaliplatin-induced sensory neurotoxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05322590
Study type	Interventional
Source	Bexion Pharmaceuticals, Inc.
Contact	Bexion Pharmaceuticals, Inc.
Phone	1-859-446-7386
Email	clinicaltrialinfo@bexionpharma.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	January 9, 2023
Completion date	April 2029

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03195868` - Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy	N/A
Not yet recruiting	`NCT05565469` - Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location	N/A
Completed	`NCT02309164` - The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).	N/A
Completed	`NCT00775645` - S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, Stage II, or Stage IIIA Breast Cancer Undergoing Chemotherapy	Phase 3
Completed	`NCT03624426` - Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery	N/A
Withdrawn	`NCT03436680` - Home-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy	N/A
Completed	`NCT05691738` - Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy	N/A
Completed	`NCT05095870` - Evaluation of the Peripheral Nerve Ultrasound as a Diagnostic Tool in CANVAS Neuropathies
Completed	`NCT02615678` - Acupuncture for CIPN in Breast Cancer Patients	N/A
Completed	`NCT02011282` - Electro-Neuro-Muscular Stimulation in ICU	N/A
Recruiting	`NCT01774058` - The Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation	Phase 2
Completed	`NCT01135251` - Safety and Preliminary Evidence of Efficacy of Escalating Doses of Dimiracetam in AIDS Patients With Painful Neuropathy	Phase 2
Recruiting	`NCT06324344` - Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)	N/A
Recruiting	`NCT04403802` - Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy	N/A
Recruiting	`NCT04579406` - Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
Recruiting	`NCT03881930` - Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy	N/A
Completed	`NCT03909464` - Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy
Completed	`NCT01523132` - Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms	N/A
Completed	`NCT02689661` - Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
Terminated	`NCT00998738` - Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma — ASIST

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms