NCT05769660

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: BeyondBio Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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)

Detailed description

In Phase 1, patients with recurrent or progressive glioblastoma multiforme who failed with the standard of care will be enrolled at each dose level of BEY1107 in combination with Temozolomide.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	BEY1107	Administer twice daily, PO, 4-week continuous dose.
COMBINATION_PRODUCT	Temozolomide	Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.

Timeline

• Start date: 2022-11-29
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2023-03-15
• Last updated: 2025-03-10

Locations

1 site across 1 country: South Korea