Clinical trial NCT06105619: A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).
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).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Glioblastoma
Lead sponsor: Beijing Pearl Biotechnology Limited Liability Company
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Overall survival(OS)
timeFrame: 5 years
Secondary outcomes:
measure: Objective Response Rate Evaluated by Investigator(ORR)
timeFrame: 5 years
measure: Progression Free Survival evaluated by Investigator(PFS)
timeFrame: 5 years
measure: Quality of Life Assessment EORTC-QLQ-C30
timeFrame: 5 years
measure: Karnofsky Performance Status score
timeFrame: 5 years
measure: Quality of Life Assessment EORTC-QLQ-BN20
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Wenbin Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Xiaoguang Qiu
role: PRINCIPAL_INVESTIGATOR
References: