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

NCT06105619 | Active Not Recruiting Phase 2

• 1 other identifier: PLB1001-Ⅱ-GBM-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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. 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. 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.
3. 3.Be given PLB1001 300mg BID,oral who were randomly assigned in test group.
4. 4.Be given Temozolomide capsules ,oral, who were randomly assigned in control group.
5. 5.Be given EP, ivgtt, who were randomly assigned in control group.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  Overall survival is defined as the time(in months)from random to the date of death.

  5 years

Secondary Outcomes (5)

• Objective Response Rate Evaluated by Investigator(ORR)

  5 years

• Progression Free Survival evaluated by Investigator(PFS)

  5 years

• Quality of Life Assessment EORTC-QLQ-C30

  5 years

• Karnofsky Performance Status score

  5 years

• Quality of Life Assessment EORTC-QLQ-BN20

  5 years

Study Arms (2)

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

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

Drug: Temozolomide; Drug: Cisplatin combined with Etoposide

Interventions

PLB1001 DRUG

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

Also known as: Vebreltinib

PLB1001

Temozolomide DRUG

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

Temozolomide or Cisplatin combined with etoposide

Cisplatin combined with Etoposide DRUG

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

Temozolomide or Cisplatin combined with etoposide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Beijing Pearl Biotechnology Limited Liability Company: lead

Study Sites (1)

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide; Etoposide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Wenbin Li

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoguang Qiu

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 27, 2023
• Study Start: October 8, 2018
• Primary Completion: April 1, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)