NCT06105619Active, not recruitingPhase 2/3
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).
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 24 Oct 2023
- Start date
- 8 Oct 2018
- Primary completion date
- 1 Apr 2023
- Lead sponsor
- Beijing Pearl Biotechnology Limited Liability Company
- Diseases
- Glioblastoma
- NCT number
- NCT06105619
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 84
- From 8 Oct 2018 to the primary completion date, 1 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
- Received antibody anti-tumor drug within 30 days before enrollment
- Previous treatment with Camustine sustained release implant
- Major surgery within 4 weeks prior to first dose of PLB1001
- Involved in other clinical trials \<30 days prior to first dose
Other illness
- Patients with active bleeding were found by brain CT or MRI scan before enrollment
- Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) 150 mm Hg and/or Diastolic Blood Pressure (DBP) ≥100 mm Hg
Other
- The subject is unable to undergo MRI scan
- Pregnant or nursing women
Who the study is looking for
- histologically confirmed secondary glioblastoma,or glioblastoma with IDH mutantation
- Must have evidence of PRPRZ1-MET fusion gene positivity from the result of molecular pre-screening evaluations
- Prior treatment with temozolomide and radiotherapy
- Stable or decreasing dose of corticosteroids within 5 days prior to the first dose
- 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
- Karnofsky performance score ≥ 60%
- Pregnant or nursing women
- Written consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.