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EGFR/EGFRvIII Inhibitor
EGFR Inhibitor for Brain Cancer
Phase 1
Recruiting
Led By Sani H. Kizilbash, M.D., M.P.H.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
EGFR Status: GBM/AA must either EGFR amplification and/or any activating EGFR mutation, NSCLC must have a confirmed activating EGFR mutation
Pre-Registration - Inclusion Criteria Specific to Dose Escalation Cohort: Histolopathological and/or molecular confirmation of either glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) or non-small cell lung cancer (NSCLC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a targeted cancer treatment that blocks the EGFR protein. The trial will study the side effects of the treatment and what the best dose is. The treatment may help patients with brain and spinal cord cancers.
Who is the study for?
This trial is for adults with certain brain cancers (glioblastoma, anaplastic astrocytoma) or lung cancer that has spread to the brain. They must have specific genetic changes in their tumors and be in good physical condition. People can't join if they've had certain heart issues, uncontrolled illnesses, severe lung disease, or are unable to stop medications that affect heart rhythm.Check my eligibility
What is being tested?
The study tests WSD0922-FU's safety and optimal dose for treating specific brain and lung cancers. It involves collecting tissue samples, imaging tests like CT and MRI scans, possibly surgery, and administering WSD0922-FU which blocks a protein involved in tumor growth.See study design
What are the potential side effects?
Potential side effects of WSD0922-FU may include risks associated with targeting the EGFR protein such as skin reactions, diarrhea, mouth sores; plus typical risks from biopsies or imaging contrast agents like bleeding or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has an EGFR mutation.
Select...
My cancer is confirmed as GBM, AA, or NSCLC through tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase 2 dose
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events
Overall response rate
+1 moreOther outcome measures
PK analysis (Cohort I) - AUC
PK analysis (Cohort I) - Clearance (CL)
PK analysis (Cohort II) - AUC
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Dose expansion Cohort III (WSD0922-FU)Experimental Treatment4 Interventions
Patients with NSCLC receive WSD0922-FU PO on days 1 and 4 of cycle 0. Patients then receive WSD0922-FU PO BID on days 1-28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans, MRI, and collection of blood and CSF samples throughout the trial.
Group II: Dose expansion Cohort II (WSD0922-FU, surgery)Experimental Treatment5 Interventions
Patients with BTP receive a single dose of WSD0922-FU prior to surgery. Patients then undergo surgical resection of brain tumor. After surgery, patients receive WSD0922-FU PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans, MRI, and collection of blood samples throughout the trial.
Group III: Dose expansion Cohort I (WSD0922-FU)Experimental Treatment4 Interventions
Patients with GBM/AA receive WSD0922-FU PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans, MRI, and collection of blood samples throughout the trial.
Group IV: Dose escalation (WSD0922-FU)Experimental Treatment4 Interventions
Patients receive WSD0922-FU PO QD or BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans, MRI, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
Wayshine Biopharm, Inc.Industry Sponsor
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,089 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,630 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I meet specific health and treatment criteria for a study phase.I do not have any severe illnesses or psychiatric conditions that are not under control.I have a heart condition that affects my heart's electrical activity.I have specific mutations and no history of severe lung disease or ongoing severe nausea, vomiting, or poor organ function.My cancer's EGFR status matches the specific requirements for the study group.My cancer has an EGFR mutation.I've had cancer treatment before, my cancer has grown, I can see my cancer on scans, and I'm mostly active.I have had previous treatments, my cancer has grown, I can show it on scans, and I can care for myself.My cancer is confirmed as GBM, AA, or NSCLC through tests.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation (WSD0922-FU)
- Group 2: Dose expansion Cohort I (WSD0922-FU)
- Group 3: Dose expansion Cohort II (WSD0922-FU, surgery)
- Group 4: Dose expansion Cohort III (WSD0922-FU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing enrollment process for this experiment?
"Per the information located on clinicaltrials.gov, this research is still in search of trial participants. It was initially posted on December 20th 2019 and recently updated on August 3rd 2022."
Answered by AI
What are the potential ramifications of utilizing WSD0922-FU as an EGFR/EGFRvIII Inhibitor?
"Our team at Power have rated the safety of EGFR/EGFRvIII Inhibitor WSD0922-FU as a 1 due to its Phase 1 classification, meaning it has limited data backing up both efficacy and safety."
Answered by AI
Could you provide an estimate of the participants currently engaged in this clinical experiment?
"Yes, the data available on clinicaltrials.gov certifies that this research project is presently seeking participants. The trial was first made public on December 20th 2019 and was recently updated by August 3rd 2022. 72 individuals need to be enrolled from across 3 medical centres."
Answered by AI
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