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

NCT ID: NCT06105619

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2026-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLB1001

Subjects will receive 300mg of PLB1001 twice daily in cycles of 4 weeks duration until death or adverse event(AE) leading to discontinuation

Group Type: EXPERIMENTAL

PLB1001

Intervention Type: DRUG

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

Temozolomide or Cisplatin combined with etoposide

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

Group Type: ACTIVE_COMPARATOR

Temozolomide

Intervention Type: DRUG

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

Cisplatin combined with Etoposide

Intervention Type: DRUG

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

Interventions

PLB1001

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

Intervention Type: DRUG

Temozolomide

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

Intervention Type: DRUG

Cisplatin combined with Etoposide

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

Intervention Type: DRUG

Other Intervention Names

Vebreltinib

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Pearl Biotechnology Limited Liability Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenbin Li

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Xiaoguang Qiu

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PLB1001-Ⅱ-GBM-01

Identifier Type: -

Identifier Source: org_study_id