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ACTIVE NOT RECRUITING
NCT06105619
PHASE2/PHASE3

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

Sponsor: Beijing Pearl Biotechnology Limited Liability Company

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2018-10-08

Completion Date

2026-12-31

Last Updated

2026-01-20

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, China