What side effects are associated with this type of intervention?

Common treatments for Anaplastic Astrocytoma include radiation therapy, chemotherapy (such as temozolomide), and targeted therapies like EGFR inhibitors. The side effects of EGFR inhibitors, similar to WSD0922-FU, often include skin rash, diarrhea, fatigue, and nausea. Broader side effects from other treatments can include myelosuppression, gastrointestinal disturbances, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Anaplastic Astrocytoma, including temozolomide, which is often used in combination with radiation therapy. Bevacizumab, an anti-VEGF antibody, has also been approved for recurrent cases. While specific EGFR inhibitors like WSD0922-FU are still under investigation, other EGFR inhibitors such as erlotinib and gefitinib have been explored in clinical trials for gliomas, including Anaplastic Astrocytoma, though they are not yet standard treatments for this condition.

What other types of research exist?

Promising novel alternatives to WSD0922-FU for Anaplastic Astrocytoma patients include: 1) Vorasidenib (AG-881), an inhibitor of mutant IDH1 and IDH2, which has shown efficacy in recurrent/progressive glioma. 2) Tumor-Treating Fields (TTF) combined with Temozolomide, which has demonstrated improved survival in glioblastoma and may be applicable to anaplastic astrocytoma. 3) Bevacizumab, an anti-VEGF antibody, which has been used in combination with other therapies for recurrent gliomas. 4) Nivolumab, a PD-1 inhibitor, which has shown activity in high-grade gliomas with mismatch repair deficiency.

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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)

Must not have

Any of the following cardiac criteria: Marked baseline prolongation of QT/corrected QT (QTc) interval, history of additional risk factors for torsade de pointes (TdP), and use of concomitant medications that prolong the QT/QTc interval

Patients confirmed to have specific mutations, past medical history of interstitial lung disease, refractory nausea and vomiting, inadequate bone marrow reserve or organ function, and other specific medical conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called WSD0922-FU for patients with aggressive brain and spinal cord cancers. The drug works by blocking a protein that helps cancer cells grow. The goal is to find the best dose and see if it can effectively treat these hard-to-treat 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.

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.

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 below

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My cancer has an EGFR mutation.

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My cancer is confirmed as GBM, AA, or NSCLC through tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart condition that affects my heart's electrical activity.

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I have specific mutations and no history of severe lung disease or ongoing severe nausea, vomiting, or poor organ function.

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I do not have any severe illnesses or psychiatric conditions that are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended phase 2 dose

Secondary study objectives

Duration of response (DOR)

Overall response rate

Progression Free Survival (PFS)

Other study objectives

PK analysis (Cohort I) - AUC

PK analysis (Cohort I) - Clearance (CL)

PK analysis (Cohort II) - AUC

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose expansion Cohort III (WSD0922-FU)Experimental Treatment5 Interventions

Patients with NSCLC receive WSD0922-FU PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI and CT during screening and on study, as well as blood sample collection on study. Patients with LM also undergo collection of CSF samples on study. Patients may also undergo optional blood sample collection on study.

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 MRI during screening and on study, as well as blood sample collection on study.

Group III: Dose expansion Cohort I (WSD0922-FU)Experimental Treatment4 Interventions

Patients with GBM/AA 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 MRI during screening and on study, as well as blood sample collection on study. Patients may undergo additional optional blood sample collection on study.

Group IV: Dose escalation (WSD0922-FU)Experimental Treatment5 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, MRI, and blood sample collection on study. Patients with NSCLC with LM also undergo collection of CSF samples on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9630

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Anaplastic Astrocytoma include EGFR inhibitors, chemotherapy, and radiation therapy. EGFR inhibitors, like WSD0922-FU, block the epidermal growth factor receptor (EGFR) protein, which is often overexpressed in Anaplastic Astrocytoma, leading to uncontrolled cell growth. By inhibiting EGFR, these treatments can slow tumor growth and potentially shrink tumors. Chemotherapy, using agents like temozolomide, works by damaging the DNA of cancer cells, preventing them from dividing and leading to cell death. Radiation therapy uses high-energy beams to destroy cancer cells and shrink tumors. These treatments are crucial for Anaplastic Astrocytoma patients as they target the aggressive nature of the tumor, aiming to control its growth and improve survival outcomes.

Phase II trial of gefitinib in recurrent glioblastoma.