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Virus Therapy

BXQ-350 for Brain Tumor (KONQUER Trial)

Phase 1

Waitlist Available

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

Must not have

Have active (acute or chronic) or uncontrolled severe infections

Have a low-grade glioma (Grade II or less)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe or uncontrolled infections.

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My brain tumor is low-grade (Grade II or less).

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My wounds do not heal well.

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I have tested positive for HIV.

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I have had previous cancer treatments like radiation or chemotherapy.

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My high blood pressure is not well-controlled despite taking medication.

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I am currently experiencing significant bleeding.

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I haven't had major surgery or recovered from its major side effects within the last 4 weeks.

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I have a history of heart problems.

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I have more than one type of cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Concentration of drug at steady state (Css)

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

Exposure to BXQ-350 - clearance (CL)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 15Eligibility criteria met