NCT06105619

A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).

A Randomized, Controlled, Open, Multicenter, Phase II/III Clinical Study to Evaluate the Safety and Efficacy of Vebreltinib Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Beijing Pearl Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of PLB1001 Enteric Capsules in the treatment of PTPRZ1-MET fusion gene positive recurrent secondary glioblastoma. The main questions it aims to answer are: 1. To evaluate overall survival (OS) in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules. 2. To evaluate if it is safety and tolerant in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules. Participants will 1. Be given PLB1001 300mg BID,oral who were randomly assigned in test group. 2. Be given Temozolomide capsules ,oral, who were randomly assigned in control group. 3. Be given EP, ivgtt, who were randomly assigned in control group.

Detailed description

84 sGBM or IDH mutant glioblastoma patients with the ZM fusion gene will be randomly divided into group A (receive vebreltinib) or group B ( receive investigator choose), and the randomize ratio will be 1:1, patients in group A will receive PLB1001 300mg Bid, 28days/cycle. Patients in group B will receive temozolomide (100-150mg/m2/d, 7 days 1 to7 and days 15 to 22 of each 28-day cycle ) or cisplatin+etoposide(cisplatin:80-100mg/m2/3 days, 28days/cycle; etoposide:100mg/m2/d, 3days, 28 days/cycle).

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	PLB1001	PLB1001 is a capsule in the form of 300mg,twice daily.
DRUG	Temozolomide	100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle
DRUG	Cisplatin combined with Etoposide	Cisplatin:80-100mg/m2/3 days,28 days/cycle Etoposide:100mg/m2/d,3 days,28 days/cycle

Timeline

• Start date: 2018-10-08
• Primary completion: 2023-04-01
• Completion: 2026-12-31
• First posted: 2023-10-27
• Last updated: 2026-01-20

Locations

1 site across 1 country: China