Continued Treatment for Participants Enrolled in Studies of BXQ-350

NCT04404569 | Terminated Phase 1 FDA Drug

• 1 other identifier: BXQ-350.AE
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

This is a study to allow continued treatment for participants enrolled in studies of BXQ-350. This study is intended only for those who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study. The additional treatment is optional and voluntary.

Conditions

Neoplasms

Keywords

High-grade Glioma; Glioblastoma; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with clinical benefit

  Subjects will be assessed at every visit for continued clinical benefit as per Investigator's assessment.

  Day 1 up to approximately 5 years

Secondary Outcomes (3)

• Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0

  Day 1 up to approximately 5 years

• Time to Disease Progression

  From Day 1 until the date of first documented disease progression or date of death from any cause, whichever occurs first; up to approximately 5 years

• Overall Survival

  From date of BXQ-350 treatment completion until time of death from any cause; up to approximately 5 years

Study Arms (1)

Continued Treatment

EXPERIMENTAL

Subjects who have completed the required study observation period or are still on treatment upon the closure of their respective BXQ-350 clinical study, and who are judged by the Investigator to benefit from continued treatment with BXQ-350. Treatment will begin after completion of the End of Study visit of the prior BXQ-350 clinical study. The established safe dose of BXQ-350 from previous adult and pediatric phase 1 studies is 2.4 mg/kg and 3.2 mg/kg respectively once every 28 days (± 3 days). BXQ-350 will be administered intravenously at the same dose level and frequency the subject was receiving at the end of the prior BXQ-350 clinical study. Subjects receiving a reduced dose at the end of the prior BXQ-350 clinical study due to toxicity may continue to receive a reduced dose.

Drug: BXQ-350

Interventions

BXQ-350 DRUG

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 is administered by intravenous (IV) infusion in 28-day cycles

Also known as: SapC-DOPS

Continued Treatment

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must meet the following criteria:
• Has participated in and completed all protocol-specified treatments through the required study observation period or time of closure for a prior Bexion-sponsored BXQ-350 clinical study
• Has completed the End of Study visit of the prior Bexion-sponsored BXQ-350 clinical study
• Did not meet any treatment discontinuation criteria of the original prior Bexion- sponsored BXQ-350 clinical study
• Investigator opinion indicates that continued treatment with BXQ-350 is clinically appropriate for the subject
• Provide signed, written informed consent prior to the initiation of any study-specific procedures (Consent from Guardians for minor children and patient assent according to Institution and Institutional Review Board (IRB) standards)
• Have a negative serum pregnancy test result within 28 days prior to the first continuing treatment assessment for females of child bearing potential (FCBP); not applicable to subjects who are unable to become pregnant, including those with tubal ligation, bilateral oophorectomy and/or hysterectomy)
• FCBP and male subjects whose sexual partner(s) are FCBP must agree to abstain from heterosexual activity or use a double barrier method of contraception (e.g., condom and occlusive cap with spermicide) or highly effective contraception (intrauterine device or system, established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle, or vasectomized partner with confirmed azoospermia) from the time of study entry to 1 month after the last day of treatment

You may not qualify if:

• Subjects must not meet any of the following criteria:
• Has any ongoing adverse event that could impact tolerability to BXQ-350
• Receiving any other non-BXQ-350 study treatment modalities with curative intent, including investigational products other than BXQ-350
• Are pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test

Sponsors & Collaborators

• Bexion Pharmaceuticals, Inc.: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (3)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

University of Cincinnati Barrett Center

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Neoplasms; Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: June 8, 2020
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)