EGFR/EGFRvIII Inhibitor WSD0922-FU for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glioblastoma+9 More
EGFR/EGFRvIII Inhibitor WSD0922-FU - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Glioblastoma
  • Metastatic Malignant Neoplasm in the Central Nervous System
  • Anaplastic Astrocytoma, IDH-Wildtype
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Metastatic Malignant Neoplasm in the Leptomeninges

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Cycle 0 Day 1
Brain
Tumor EGFR inhibition after a single dose of WSD0922-FU (Dose Expansion - Brain tumor penetration (BTP) cohort only).
Day 4
Effect of food on Area under the plasma concentration versus time curve (AUC) of WSD022-FU after a single dose of WSD0922-FU (Dose Expansion - NSCLC LM cohort only).
Effect of food on Maximum plasma Concentration [Cmax] of WSD0922-FU after a single dose of WSD0922-FU (Dose Expansion - NSCLC LM cohort only).
Day 15
Area under the plasma concentration versus time curve (AUC) of WSD022-FU after multiple doses of WSD0922-FU
Maximum plasma Concentration [Cmax] of WSD0922-FU after multiple doses of WSD0922-FU
Day 1
Maximum plasma Concentration [Cmax] of WSD0922-FU after a single dose of WSD0922-FU
Cycle 2 Day 1
CSF concentration of WSD0922-FU after multiple doses of WSD0922-FU (Dose Expansion - NSCLC leptomeningeal metastases (NSCLC LM) cohort only).
Year 5
Progression Free Survival (PFS)
Year 5
Duration of response (DOR)
Day 1
Area under the plasma concentration versus time curve (AUC) of WSD022-FU after a single dose of WSD0922-FU
Up to 28 days
Recommended phase 2 dose
Week 6
Incidence of adverse events
Up to 5 years
Overall response rate

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Dose expansion Cohort II (WSD0922-FU, surgery)
1 of 4
Dose escalation (WSD0922-FU)
1 of 4
Dose expansion Cohort III (WSD0922-FU)
1 of 4
Dose expansion Cohort I (WSD0922-FU)
1 of 4
Experimental Treatment

72 Total Participants · 4 Treatment Groups

Primary Treatment: EGFR/EGFRvIII Inhibitor WSD0922-FU · No Placebo Group · Phase 1

Dose expansion Cohort II (WSD0922-FU, surgery)Experimental Group · 2 Interventions: Therapeutic Conventional Surgery, EGFR/EGFRvIII Inhibitor WSD0922-FU · Intervention Types: Procedure, Drug
Dose escalation (WSD0922-FU)
Drug
Experimental Group · 1 Intervention: EGFR/EGFRvIII Inhibitor WSD0922-FU · Intervention Types: Drug
Dose expansion Cohort III (WSD0922-FU)
Drug
Experimental Group · 1 Intervention: EGFR/EGFRvIII Inhibitor WSD0922-FU · Intervention Types: Drug
Dose expansion Cohort I (WSD0922-FU)
Drug
Experimental Group · 1 Intervention: EGFR/EGFRvIII Inhibitor WSD0922-FU · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Wayshine Biopharm, Inc.Industry Sponsor
Mayo ClinicLead Sponsor
2,892 Previous Clinical Trials
3,698,665 Total Patients Enrolled
9 Trials studying Glioblastoma
237 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,816 Total Patients Enrolled
301 Trials studying Glioblastoma
22,366 Patients Enrolled for Glioblastoma
Sani H KizilbashPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The diagnosis must be confirmed by either histopathological or molecular analysis.
You have EGFR amplification and/or any activating EGFR mutation.
You have EGFR amplification and/or any activating EGFRvIII mutation.
You have EGFR amplification and/or any activating EGFRvIII mutation based on prior resection.
You have a diagnosis of non-small cell lung cancer (NSCLC).
The study is a dose escalation study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.