GlioblastomaPhase 2/3NCT06105619
A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
A Phase 2/3 study testing PLB1001, Temozolomide and Cisplatin combined with Etoposide in people with Glioblastoma, run by Beijing Pearl Biotechnology Limited Liability Company at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- PLB1001, Temozolomide and Cisplatin combined with Etoposide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2018to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- The subject is unable to undergo MRI scan
- 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
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- Major surgery within 4 weeks prior to first dose of PLB1001
- Pregnant or nursing women
- Involved in other clinical trials <30 days prior to first dose
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
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).
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:
- To evaluate overall survival (OS) in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules.
- 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.
Read more
Participants will
- Be given PLB1001 300mg BID,oral who were randomly assigned in test group.
- Be given Temozolomide capsules ,oral, who were randomly assigned in control group.
- Be given EP, ivgtt, who were randomly assigned in control group.
Read the 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
- Being tested
- PLB1001, Temozolomide, Cisplatin combined with Etoposide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLB1001Drug
Also called Vebreltinib
PLB1001 is a capsule in the form of 300mg,twice daily.
TemozolomideDrug
100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle
Cisplatin combined with EtoposideDrug
Cisplatin:80-100mg/m2/3 days,28 days/cycle Etoposide:100mg/m2/d,3 days,28 days/cycle
| Study group | Role | What they receive |
|---|---|---|
| PLB1001 | Experimental | Subjects will receive 300mg of PLB1001 twice daily in cycles of 4 weeks duration until death or adverse event(AE) leading to discontinuation Receives: Drug: PLB1001 |
| Temozolomide or Cisplatin combined with etoposide | Active comparator | Investigators can choose one of two treatments
1. Dose density of temozolomide：100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle
2. Cisplatin combined with etoposide：Cisplatin,80-100mg/m2/3 days,28 days/cycle.etoposide, 100mg/m2/d,3 days,28 days/cycle Receives: Drug: Temozolomide; Drug: Cisplatin combined with Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
Overall survival is defined as the time(in months)from random to the date of death.
Measured: 5 years
Secondary outcomes (5)
Objective Response Rate Evaluated by Investigator(ORR)
Objective response rate will be determined according to response assessment in neuro-oncology(RANO).
Measured: 5 years
Progression Free Survival evaluated by Investigator(PFS)
Progression Free Survival is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD or death due to any cause.
Measured: 5 years
Quality of Life Assessment EORTC-QLQ-C30
The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures. These include the Physical Functioning Scale and four more functional scales (role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status / QoL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Measured: 5 years
Karnofsky Performance Status score
improved is defined as KPS increases >10 after treatment; worsen is defined as KPS decreases >10; stable is defined as KPS changes ≤10.
Measured: 5 years
Quality of Life Assessment EORTC-QLQ-BN20
The EORTC-QLQ-BN20 covers future uncertainty, visual disorder, motor dysfunction, communication deficit, headache, seizures, drowsiness, hair loss, itching, difficulty with bladder control, and weakness of both legs. Patients respond by self-report, with most items rated on a 4-point scale, from 1 "not at all" to 4 "very much", except for the two global health status/quality of life items, which are measured on a 7-point Likert scale ("very poor" through "excellent"). The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start8 Oct 2018
- Primary completion1 Apr 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Pearl Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenbin Li, Principal investigator, Beijing Tiantan HospitalXiaoguang Qiu, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105619
- Sponsor's protocol ID
- PLB1001-Ⅱ-GBM-01
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06105619
- Acronym / sponsor ID
- PLB1001-Ⅱ-GBM-01
- Conditions
- Glioblastoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Beijing Pearl Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate overall survival (OS) in the treatment of secondary glioblasts with positive recurrence of PTPRZ1-MET (ZM) fusion gene by PLB1001 Enteric Capsules.
- 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
- Be given PLB1001 300mg BID,oral who were randomly assigned in test group.
- Be given Temozolomide capsules ,oral, who were randomly assigned in control group.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLB1001 | Experimental | Drug: PLB1001Subjects will receive 300mg of PLB1001 twice daily in cycles of 4 weeks duration until death or adverse event(AE) leading to discontinuation |
| Temozolomide or Cisplatin combined with etoposide | Active comparator | Drug: Temozolomide, Drug: Cisplatin combined with EtoposideInvestigators can choose one of two treatments 1. Dose density of temozolomide：100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle 2. Cisplatin combined with etoposide：Cisplatin,80-100mg/m2/3 days,28 days/cycle.etoposide, 100mg/m2/d,3 days,28 days/cycle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- The subject is unable to undergo MRI scan
- Patients with active bleeding were found by brain CT or MRI scan before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLB1001Also: VebreltinibPLB1001 is a capsule in the form of 300mg,twice daily. | Drug | PLB1001 |
| Temozolomide100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle | Drug | Temozolomide or Cisplatin combined with etoposide |
| Cisplatin combined with EtoposideCisplatin:80-100mg/m2/3 days,28 days/cycle Etoposide:100mg/m2/d,3 days,28 days/cycle | Drug | Temozolomide or Cisplatin combined with etoposide |
Primary outcome
Overall survival(OS)
Time frame: 5 years
Overall survival is defined as the time(in months)from random to the date of death.
5 secondary outcomes
Objective Response Rate Evaluated by Investigator(ORR)
Time frame: 5 years
Progression Free Survival evaluated by Investigator(PFS)
Time frame: 5 years
Quality of Life Assessment EORTC-QLQ-C30
Time frame: 5 years
Karnofsky Performance Status score
Time frame: 5 years
Quality of Life Assessment EORTC-QLQ-BN20
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenbin Li principal investigator
Beijing Tiantan Hospital
Xiaoguang Qiu principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PLB1001, Temozolomide and Cisplatin combined with Etoposide in people with Glioblastoma, run by Beijing Pearl Biotechnology Limited Liability Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival(OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.