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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06105619
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Beijing Pearl Biotechnology Limited Liability Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Wenbin LiXiaoguang Qiu
Principal Investigator Affiliation Beijing Tiantan HospitalBeijing Tiantan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

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).

Arms & Interventions

Arms

Experimental: PLB1001

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

Active Comparator: 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

Interventions

Drug: - PLB1001

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

Drug: - Temozolomide

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

Drug: - Cisplatin combined with Etoposide

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Address

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing, 100070

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