RecruitingPhase 1NCT05769660

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)

An Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patient with Recurrent or Progressive Glioblastoma Multiforme (GBM)


Sponsor

BeyondBio Inc.

Enrollment

12 participants

Start Date

Nov 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing BEY1107 combined with temozolomide (standard chemotherapy) in patients with glioblastoma (GBM) — a severe brain cancer — that has come back or is growing again after initial treatment. **You may be eligible if...** - You are 19 years old or older - You have confirmed glioblastoma that has progressed or returned after standard first-line treatment - You have at least one measurable or evaluable tumor on brain imaging - You are in good overall health (ECOG 0–1) - If on steroids, your dose is stable **You may NOT be eligible if...** - Your glioblastoma is newly diagnosed (not yet treated) - You are in poor health or have organ dysfunction - You have certain medical conditions that interfere with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBEY1107

Administer twice daily, PO, 4-week continuous dose.

COMBINATION_PRODUCTTemozolomide

Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.


Locations(1)

Seoul National University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05769660


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