Spots Global Cancer Trial Database for BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
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Trial Identification
Brief Title: BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
Official Title: A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination With mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma
Study ID: NCT05322590
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
UC Irvine Health, Orange, California, United States
Pacific Hematology Oncology Associates, San Francisco, California, United States
Sylvester Comprehensive Cancer Center, University of Miami Hospitals and Clinics, Miami, Florida, United States
The University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
St. Elizabeth Healthcare, Edgewood, Kentucky, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
University of Louisville, James Graham Brown Cancer Center, Louisville, Kentucky, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Stony Brook Cancer Center, Stony Brook, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Providence Cancer Institute Franz Clinic, Portland, Oregon, United States
Prisma Health, Institute for Translational Oncology Research, Greenville, South Carolina, United States
Contact Details
Name: Chief Scientific Officer
Affiliation: Bexion Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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