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Continued Treatment for Participants Enrolled in Studies of BXQ-350

NCT ID: NCT04404569

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2024-09-23

Brief Summary

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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.

Detailed Description

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This is an open-label, multi-center, rollover study to allow continued treatment access for participants enrolled in studies of BXQ-350. This study is intended for 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. The additional treatment is optional and voluntary.

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

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Neoplasms

Keywords

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High-grade Glioma Glioblastoma Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continued Treatment

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.

Group Type EXPERIMENTAL

BXQ-350

Intervention Type 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

Interventions

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

Intervention Type DRUG

Other Intervention Names

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SapC-DOPS

Eligibility Criteria

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Inclusion Criteria

* Each subject must meet the following criteria:

1. 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
2. Has completed the End of Study visit of the prior Bexion-sponsored BXQ-350 clinical study
3. Did not meet any treatment discontinuation criteria of the original prior Bexion- sponsored BXQ-350 clinical study
4. Investigator opinion indicates that continued treatment with BXQ-350 is clinically appropriate for the subject
5. 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)
6. 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)
7. 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

Exclusion Criteria

* Subjects must not meet any of the following criteria:

1. Has any ongoing adverse event that could impact tolerability to BXQ-350
2. Receiving any other non-BXQ-350 study treatment modalities with curative intent, including investigational products other than BXQ-350
3. 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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CTI Clinical Trial and Consulting Services

OTHER

Sponsor Role collaborator

Bexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Site Status

University of Cincinnati Barrett Center

Cincinnati, Ohio, United States

Site Status

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BXQ-350.AE

Identifier Type: -

Identifier Source: org_study_id