Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT02978261
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent Form
* Age≥18 years
* Histologically or cytologically confirmed recurrent high-grade glioma after concurrent or adjuvant chemoradiotherapy
* Prior treatment with temozolomide
* Must have evidence of PTPRZ1-MET fusion gene positivity from the results of molecular pre-screening evaluations
* At least one measurable lesion as per RANO
* No evidence of recent haemorrhage on baseline MRI of the brain
* Stable or decreasing dose of corticosteroids within 5 days prior to the first dose
* Major surgery within 4 weeks prior to first dose of PLB1001
* Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 6 weeks before first dose of PLB1001
* Pregnant or nursing women
* Involved in other clinical trials \<30 days prior to first dose
* Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the patient must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field
* Karnofsky performance status ≥ 50%
Exclusion Criteria:
* Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
* The subject is unable to undergo MRI scan (e.g. has pacemaker)
* Clinically significant, uncontrolled heart diseases： Unstable angina; History of documented congestive heart failure (New York Heart Association functional classification\> II); Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 145 mm Hg and/or Diastolic Blood Pressure (DBP) ≥85 mm Hg; Arrhythmias.
* Active peptic ulcer disease or gastritis
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
* Major surgery within 4 weeks prior to first dose of PLB1001
* Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 6 weeks before first dose of PLB1001
* Pregnant or nursing women
* Involved in other clinical trials \<30 days prior to first dose
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02978261
Study Brief:
Protocol Section:
NCT02978261