Suspended

Defactinib or VS-6766 Accumulation in Glioblastoma

Study Aim

This early phase 1 study aims to determine how much of the drugs defactinib and VS-6766 accumulate in the brain tumor and surrounding brain tissue in patients with glioblastoma, while also monitoring any side effects experienced.

What is being tested

Avutometinib

+ Biospecimen Collection

+ Defactinib

DrugProcedure

Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

Over 21 Years

+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1

Interventional

Study Start: July 2023

See protocol details

Summary

Principal SponsorEmory University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 28, 2023

Actual date on which the first participant was enrolled.

This clinical trial is focused on patients with glioblastoma, a type of brain cancer. The study aims to understand how two medications, Defactinib and VS-6766, behave within the brain and tumor tissue of these patients. Researchers want to see how much of these medications accumulate in the tumor and surrounding brain tissue. They are also interested in how these drugs affect certain cellular pathways that are important in cancer growth, specifically Pyk2/FAK and MEK/Erk signaling. This research is important because understanding how these drugs interact with brain tumors could lead to better treatment options for glioblastoma, a condition that currently has limited effective therapies. Participants in this study are divided into two groups. One group receives a single oral dose of Defactinib, and the other receives a single oral dose of VS-6766. This is done before they undergo planned tumor removal surgery. As part of the study, blood samples and tumor tissue are collected from participants to measure drug concentrations. Researchers also monitor for any side effects, such as fatigue, nausea, or skin rash, to assess the safety of these medications. The data collected will help determine the best dose levels and provide insights into the potential benefits and risks of these drugs for treating brain tumors.

Official TitleA Single-Dose Study of Orally Administrated Defactinib or VS-6766 in Patients With Glioblastoma

NCT05798507

Principal SponsorEmory University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

15 inclusion criteria required to participate

Age older than 21 years

Albumin \>= 3.0 g/dL (451 umole/L)

New or recurrent glioblastoma diagnosed by neuroimaging techniques for which surgical resection is indicated

An Eastern Cooperative Group (ECOG) performance status =\< 1

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15 exclusion criteria prevent from participating

History of rhabdomyolysis

Clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulation or potent CYP 2C8 inhibitors, and history of clinically significant cardiac or pulmonary disorders

Minors will be excluded from the investigation. Glioblastoma is the major form of brain cancer in people over 50 years old. Pediatric cases of glioblastoma are relatively rare. Besides this, there are crucial molecular differences between adult and pediatric gliomas. Our preliminary data for proposed investigation were obtained on GBM specimens and cultures developed from GBM tissues donated by adult subjects. Results of investigation of adult glioma tissue cannot simply be extrapolated to children. Therefore, our primary research focus is the investigation of GBM in adults. If appropriate, a separate, age-specific study in children will be performed

Pregnant women will be excluded from the study as altered hormonal and immunological status can affect the study results

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients receive 1 dose of avutometinib PO while on study, prior to planned tumor resection. Patients undergo blood collection and donate resected tumor tissue while on study.

Group II

Experimental

Patients receive 1 dose of defactinib PO while on study, prior to planned tumor resection. Patients undergo blood collection and donate resected tumor tissue while on study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Emory University Hospital/Winship Cancer Institute

Atlanta, United StatesOpen Emory University Hospital/Winship Cancer Institute in Google Maps

SuspendedOne Study Center