Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT06105619
Active, not recruiting Phase 2/3

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

NCT06105619 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Pearl Biotechnology Limited Liability Company
Phase
Phase 2/3
Started
2018-10-08
Last updated
2026-01-20

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

PLB1001 →Temozolomide →Cisplatin combined with EtoposideAll Cisplatin trials (514) →All Etoposide trials (164) →

PLB1001: PLB1001 is a capsule in the form of 300mg,twice daily.

Temozolomide: 100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle

Cisplatin combined with Etoposide: Cisplatin:80-100mg/m2/3 days,28 days/cycle Etoposide:100mg/m2/d,3 days,28 days/cycle

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. histologically confirmed secondary glioblastoma,or glioblastoma with IDH mutantation 2. Must have evidence of PRPRZ1-MET fusion gene positivity from the result of molecular pre-screening evaluations 3. Prior treatment with temozolomide and radiotherapy 4. Stable or decreasing dose of corticosteroids within 5 days prior to the first dose 5. Platelet count≥75×109/L,Neutrophilic granulocyte count≥1.5×109/L, Hemoglobin\>90g/L,AST or ALT \< 3 times the lab's upper normal limit,Serum creatinine \< 1.5 times the lab's upper normal limit,INR≤2.0 6. Karnofsky performance score ≥ 60% 7. Pregnant or nursing women 8. Written consent Exclusion Criteria: 1. Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy 2. Received antibody anti-tumor drug within 30 days before enrollment 3. Previous treatment with Camustine sustained release implant 4. The subject is unable to undergo MRI scan 5. Patients with active bleeding were found by brain CT or MRI scan before enrollment 6. Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) 150 mm Hg and/or Diastolic Blood Pressure (DBP) ≥100 mm Hg 7. Major surgery within 4 weeks prior to first dose of PLB1001 8. Pregnant or nursing women 9. Involved in other clinical trials \<30 days prior to first dose

Primary outcome measure(s)

  • Overall survival(OS) — 5 years
    Overall survival is defined as the time(in months)from random to the date of death.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tiantan Hospital,Capital Medical University Beijing Beijing Municipality

More Beijing Pearl Biotechnology Limited Liability Company trials in China

A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2) Recruiting
A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive Recruiting

Other trials for the same condition

Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma Active, not recruiting
Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma Starting soon
Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma Recruiting
Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma Recruiting
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06105619 on ClinicalTrials.gov ↗ ← All trials in China