WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases
NCT04197934 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2026-03-30
Summary
This phase I trial studies the side effects and best dose of WSD0922-FU for the treatment of glioblastoma, anaplastic astrocytoma, or non-small cell lung cancer that has spread to the central nervous system (central nervous system metastases). WSD0922-FU is a targeted treatment which blocks the EGFR protein - a strategy that has led to a lot of benefit in patients with many different cancers. WSD0922-FU may also be able to get into cancers in the brain and spinal cord and help patients with brain and spinal cord cancers.
Funding Source - FDA OOPD
Conditions
- Anaplastic Astrocytoma, IDH-Wildtype
- Glioblastoma, IDH-Wildtype
- Metastatic Lung Non-Small Cell Carcinoma
- Metastatic Malignant Neoplasm in the Central Nervous System
- Stage IV Lung Cancer AJCC v8
Interventions
- PROCEDURE
-
Biospecimen Collection - blood samples
Undergo collection of blood samples
- PROCEDURE
-
Biospecimen Collection - CSF samples
Undergo collection of CSF samples
- PROCEDURE
-
Computed Tomography
Undergo CT
- DRUG
-
EGFR/EGFRvIII Inhibitor WSD0922-FU
Given PO
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Therapeutic Conventional Surgery
Undergo surgical resection
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Sani H. Kizilbash, M.D., M.P.H. · Mayo Clinic in Rochester
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-20
- Primary Completion
- 2022-10-30
- Completion
- 2031-02-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas
NCT02015819 ·Status: COMPLETED ·Phase: PHASE1
-
Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma
NCT04477200 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of DC Vaccination Against Glioblastoma
NCT01567202 ·Status: UNKNOWN ·Phase: PHASE2
-
Testing the Safety of M6620 (VX-970) When Given With Standard Whole Brain Radiation Therapy for the Treatment of Brain Metastases From Non-small Cell Lung Cancer, Small Cell Lung Cancer, or Neuroendocrine Tumors
NCT02589522 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00082797 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection
NCT01419067 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients with EGFR Activated Recurrent Glioblastoma
NCT03732352 ·Status: COMPLETED ·Phase: PHASE2
-
Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases
NCT03796273 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Phase I Vorinostat Concurrent With Stereotactic Radiosurgery (SRS) in Brain Metastases From Non-Small Cell Lung Cancer
NCT00946673 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors
NCT01111097 ·Status: COMPLETED ·Phase: PHASE1
-
Neurocognitive Decline in Patients With Brain Metastases
NCT03508752 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastoma
NCT03452930 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
NCT06757153 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
NCT02861898 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan
NCT00562419 ·Status: UNKNOWN ·Phase: PHASE2
-
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
NCT00085202 ·Status: COMPLETED ·Phase: PHASE3
-
STAT3 Inhibitor WP1066 in Treating Patients With Recurrent Malignant Glioma or Progressive Metastatic Melanoma in the Brain
NCT01904123 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms
NCT00004688 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
NCT00463008 ·Status: COMPLETED ·Phase: NA
-
Gossypol in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
NCT00540722 ·Status: COMPLETED ·Phase: PHASE2
-
Hypofractionated Stereotactic Radiotherapy With Anlotinib in Patients With Recurrent High-Grade Gliomas
NCT04197492 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma
NCT04047303 ·Status: TERMINATED ·Phase: PHASE1
-
Cediranib Maleate and Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer
NCT00937482 ·Status: TERMINATED ·Phase: PHASE1
-
AZD8055 for Adults With Recurrent Gliomas
NCT01316809 ·Status: COMPLETED ·Phase: PHASE1
-
GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery
NCT00980343 ·Status: COMPLETED ·Phase: PHASE2