NCT05291286

BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients

A Pilot Proof of Concept Pharmacokinetic/Pharmacodynamic Study of BXQ-350 in Cancer Patients Exposed to Oxaliplatin and/or Taxane-Based Chemotherapy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Bexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized, placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.

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 SapC-DOPS along with its proven safety profile and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to test on cancer patients affected by CIPN. The aim of this pilot proof-of-concept study is to assess PK/PD relationships in cancer patients with CIPN symptoms in order to determine the impact BXQ-350 has on ceramide, S1P, and inflammatory cytokine levels; thereby potentially reducing the intensity and/or duration of CIPN, improving QoL, and establishing these signaling molecules as biomarkers in future studies. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Conditions

• Neuropathy;Peripheral
• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	BXQ-350	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 phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 will be administered by intravenous (IV) infusion
OTHER	Placebo	Placebo will be 0.9% normal saline of matching volume to BXQ-350 administered by intravenous (IV) infusion

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2022-03-22
• Last updated: 2025-01-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study