Enrollment has been completed for the phase 1b/2 ASIST study that is evaluating BXQ-350 in combination with standard-of-care treatments in patients with newly diagnosed metastatic colorectal cancer.
Trial Name: 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
ClinicalTrials.gov Identifier: NCT05322590
Sponsor: Bexion Pharmaceuticals, Inc.
Recruitment Contact: Bexion Pharmaceuticals, Inc., 1-859-446-7386, clinicaltrialinfo@bexionpharma.com
Completion Date: April 2029
The open-label portion of the phase 1b/2 ASIST study (NCT05322590) evaluating the combination of BXQ-350 plus standard of care (SOC) for the first-line treatment of patients with metastatic colorectal cancer (mCRC) has completed patient enrollment.1
BXQ-350 is a first-in-class biologic that contains the multifunctional sphingolipid activator protein, Saposin C, and a phospholipid. Multiple phase 1 trials of the agent in adult and pediatric patients have shown there to be a robust safety profile and evidence of single-agent activity across various types of solid tumors. Both clinical and non-clinical data suggest that BXQ-350 has activity in chemotherapy-induced peripheral neuropathy.1
ASIST plans to evaluate the safety and efficacy of BXQ-350 in combination with SOC, which consists of modified FOLFOX7 (mFOLFOX7) and bevacizumab (Avastin), for the treatment of patients with newly diagnosed mCRC. Investigators are also testing whether the BXQ-350 plus mFOLFOX7 and bevacizumab may diminish chemotherapy-induced peripheral neuropathy (CIPN).
"I am delighted that Bexion has completed enrollment for its phase 1b/2 clinical trial and am especially pleased my clinical site has made significant contributions toward this effort," said Reema A. Patel, MD, associate professor of medicine at the Markey Cancer Center of the University of Kentucky, in a press release. "BXQ-350's mechanism of action lends itself to potential benefit in [patients with] metastatic colorectal [cancer] and peripheral neuropathy. Severe neuropathy is a key reason that patients drop off chemotherapy for colorectal cancer, and BXQ-350 has been shown to possess potential anti-neuropathy properties. I am excited by the potential of BXQ-350 to reduce or even potentially reverse neuropathic pain in these patients."
In the ASIST study, investigators plan to examine the safety and efficacy of BXQ-350 plus mFOLFOX7 and bevacizumab in patients with newly diagnosed metastatic adenocarcinoma of the colon/rectum and whether the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish oxaliplatin induced sensory neurotoxicity, enabling participants to receive total, planned doses of mFOLFOX7.2
Enrollment is open to patients aged 18 years or older with newly diagnosed stage IV metastatic adenocarcinoma of the colon/rectum. Patients are required to have measurable disease at baseline based on RECIST 1.1 as determined by the local site investigator/radiology assessment, a life expectancy of at least 3 months, and an ECOG performance status of 0 or 1. Additionally, patients must have acceptable liver, renal, and bone marrow function, and acceptable coagulation parameters.2
Once enrolled in the study, patients will receive BXQ-350 via intravenous (IV) infusion plus SOC doses of mFOLFOX and bevacizumab. The study includes 2 stages: Stage 1 is the open-label portion which includes patients who will receive increasing doses of BXQ-350. This stage aims to determine the dose that will be used in stage 2. Then, stage 2 is blinded and patients will receive either BXQ-350 at the established stage 1 dose or placebo.2
The primary end points are to determine the recommended phase 2 dose, incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, and objective response rate. Secondary end points include overall survival, progression-free survival, duration of response, disease control rate, peak plasma concentration, total sensory neuropathy. CIPN assessment, and post oxaliplatin assessment.
The estimated study completion date is April 2029, and patients are currently being enrolled at sites in Alabama, California, Florida, Iowa, Kentucky, Louisiana, New York, Ohio, Oregon, and South Carolina.
"We extend our gratitude to all the patients, clinical investigators, and site research staff who continue to contribute to the advances we are making," said Jim Beach, chief executive officer of Bexion, in the press release.1 "We are excited about advancing to the next stage of clinical development, including further discussions with FDA on study design, and we look forward to providing updates as we reach upcoming milestones in 2025."
