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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).
Beijing Pearl Biotechnology Limited Liability Company·Phase 2/3·ClinicalTrials.gov·drugRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Glioblastoma
Drug/Device/Intervention
PLB1001
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Beijing Pearl Biotechnology Limited Liability Company
Location
Beijing, China
Timeline & enrollment
Phase
Phase 2/3
Start date
Oct 08, 2018
End date
Dec 31, 2024
Enrollment
84 participants
Primary outcome

Overall survival(OS)

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.

ICD-10 classifications
Malignant neoplasm of brainMalignant neoplasm: Brain, unspecifiedMesotheliomaMalignant neoplasm: Brain stemMalignant neoplasm: Overlapping lesion of brain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06105619
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06105619 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Beijing Pearl Biotechnology Limited Liability Company and is currently Recruitment Completed. The study focuses on Glioblastoma. Target enrollment is 84 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.