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Virus Therapy

BXQ-350 for Brain Tumor (KONQUER Trial)

Q: Has the FDA approved BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance?

Our experts at Power place the safety of BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance on a scale from one to three with a score of one, as this is only in Phase One. Thus far, there have been limited trials indicating its efficacy and safety.

Q: How many participants are currently enrolled in this trial?

Affirmative. The facts on clinicaltrials.gov suggest that this scientific investigation is actively searching for volunteers; it was initially posted on May 24th 2021 and last updated on October 3rd 2022, with 22 individuals being sought from three distinct sites.

Q: What purpose is this medical investigation hoping to accomplish?

This clinical trial, which will run for an approximated 12 months, is primarily focused on establishing the Maximum Tolerated Dose. Secondary assessment goals include calculating area under the curve to measure exposure to BXQ-350 in newly diagnosed patients with DIPG or DMG receiving radiation therapy and gauging Objective Response Rate as well as volume of distribution.

Q: Are individuals aged 40 or more accepted into this research study?

This investigation is open to participants aged 1 and above, but below 30 years old.

Phase 1

Recruiting

Research Sponsored by Bexion Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 1 year and ≤ 30 years at the time of study entry

Newly-diagnosed DIPG or DMG planning to undergo biopsy at the recommendation of the treating physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

KONQUER Trial Summary

This trial will test the safety of BXQ-350 in children with newly diagnosed brain tumors, with the goal of determining the maximum tolerated dose. BXQ-350 will be given by IV infusion, along with radiation therapy. The study will enroll patients at increasing dose levels of BXQ-350, in order to determine the maximum tolerated dose.

Who is the study for?

This trial is for children and young adults aged 1 to 30 with newly diagnosed DIPG or DMG brain tumors. Participants must have a certain level of physical ability, adequate organ function, and no prior malignancies or treatments for their condition. Females who can bear children must test negative for pregnancy and agree to contraception.Check my eligibility

What is being tested?

The study tests the safety of BXQ-350 given via IV alongside radiation therapy in two parts: finding the highest dose kids can tolerate without severe side effects (MTD), and measuring how much drug gets into the tumor when given at that dose.See study design

What are the potential side effects?

Specific side effects are not listed but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, liver or kidney issues. The trial aims to determine what these are at various doses.

KONQUER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 30 years old.

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I have a new diagnosis of DIPG or DMG and am planning a biopsy.

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I agree to use contraception or abstain from sex during and for 1 month after the study.

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I have a new diagnosis of DIPG or DMG confirmed by imaging or biopsy.

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I can do most activities by myself, regardless of my age.

KONQUER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Part 1 - Maximum Tolerated Dose

Part 2 - BXQ-350 Concentration in Plasma Samples

+1 more

Secondary outcome measures

Concentration of drug at steady state (Css)

Exposure to BXQ-350 - area under the curve (AUC)

Exposure to BXQ-350 - clearance (CL)

+5 more

KONQUER Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 BXQ-350 Tumor and Plasma ConcentrationsExperimental Treatment1 Intervention

Newly diagnosed DIPG or DMG patients undergoing neurosurgical biopsy prior to receiving radiation therapy will receive BXQ-350 at the MTD established in Part 1, or the highest planned dose level, and radiation therapy. Excised tumor tissue and plasma samples will be evaluated for SapC levels and pharmacodynamic effects.

Group II: Part 1 Dose Escalation: Safety and ToleranceExperimental Treatment1 Intervention

Sequential cohorts of patients with newly diagnosed DIPG or DMG will be treated with escalating doses of BXQ-350 until the maximum tolerated dose (MTD) is established, or in the absence of a maximum administered dose (MAD), the highest planned dose level is reached and radiation therapy.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bexion Pharmaceuticals, Inc.Lead Sponsor

5 Previous Clinical Trials

360 Total Patients Enrolled

CTI Clinical Trial and Consulting ServicesOTHER

34 Previous Clinical Trials

3,713 Total Patients Enrolled

Media Library

BXQ-350 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04771897 — Phase 1

Diffuse Intrinsic Pontine Glioma Research Study Groups: Part 2 BXQ-350 Tumor and Plasma Concentrations, Part 1 Dose Escalation: Safety and Tolerance

Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: BXQ-350 Highlights & Side Effects. Trial Name: NCT04771897 — Phase 1

BXQ-350 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04771897 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled for this trial?

"Affirmative, the information found on clinicaltrials.gov indicates that this research is actively recruiting at present. The trial was initially posted in May 2021 and revised last October 2022; it intends to enroll 22 participants from 3 sites."

Answered by AI

Who is eligible for inclusion in this clinical trial?

"This precise clinical trial is enrolling 22 participants with diffuse intrinsic pontine glioma (DIPG) or its variant, dorsally-extended midbrain gliomas (DMG), aged between 1 and 30. The salient criteria for enrolment include: being older than one year of age but younger than thirty; imaging characteristics matching those noted in the literature; inability to walk due to paralysis while still being able to control a wheelchair unassisted; biopsy necessary if disease does not fit classic profile; measurable/non-measurable RANO metrics showing tumour presence; minimum 50% viable tumor cells amongst <30"

Answered by AI

Has the FDA approved BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance?

"Our experts at Power place the safety of BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance on a scale from one to three with a score of one, as this is only in Phase One. Thus far, there have been limited trials indicating its efficacy and safety."

Answered by AI

How many participants are currently enrolled in this trial?

"Affirmative. The facts on clinicaltrials.gov suggest that this scientific investigation is actively searching for volunteers; it was initially posted on May 24th 2021 and last updated on October 3rd 2022, with 22 individuals being sought from three distinct sites."

Answered by AI

What purpose is this medical investigation hoping to accomplish?

"This clinical trial, which will run for an approximated 12 months, is primarily focused on establishing the Maximum Tolerated Dose. Secondary assessment goals include calculating area under the curve to measure exposure to BXQ-350 in newly diagnosed patients with DIPG or DMG receiving radiation therapy and gauging Objective Response Rate as well as volume of distribution."

Answered by AI