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Small Molecule Inhibitor

Tepotinib +/- Osimertinib for Brain Cancer

Phase 1
Waitlist Available
Led By Barbara O'Brien, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Group B: Histiologically-confirmed WHO grade IV glioma (glioblastoma or gliosarcoma) with MET alteration identified through molecular testing
Phase 1a, Group C and Phase 1b, Groups A and C participants must have small, minimally symptomatic/asymptomatic brain metastasis that do not require surgical resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will assess the safety and efficacy of tepotinib in patients with brain tumors and MET alterations. The study will be conducted in two parts, with the first part exploring different doses of the drug and the second part expanding upon the most promising dose from the first part.

Who is the study for?
This trial is for adults with brain tumors or metastases who have MET alterations. It includes those with glioblastoma, patients who've had prior cancer treatments, and NSCLC patients resistant to EGFR-TKI therapy with MET amplification. Participants must be in good physical condition, not pregnant or breastfeeding, willing to use birth control, and able to undergo lumbar puncture without medical risks.Check my eligibility
What is being tested?
The study tests the drug tepotinib alone or combined with osimertinib in people with brain tumors due to MET gene changes. The first phase determines safe dosages while the second expands testing at these doses. Some participants will also undergo surgery as part of their treatment evaluation.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related responses (like fever or chills), fatigue, digestive issues like nausea or diarrhea, blood cell count changes which can affect immunity and healing capacity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the recommended phase II dose (RP2D) of tepotinib for patients with brain metastasis and MET alterations (Group A)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
will receive tepotinib and osimertinib
Group II: Group AExperimental Treatment1 Intervention
will receive tepotinib alone

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,964 Previous Clinical Trials
1,804,358 Total Patients Enrolled
Barbara O'Brien, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
4,675 Total Patients Enrolled

Media Library

Tepotinib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05120960 — Phase 1
Brain Tumor Research Study Groups: Group B, Group A
Brain Tumor Clinical Trial 2023: Tepotinib Highlights & Side Effects. Trial Name: NCT05120960 — Phase 1
Tepotinib (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05120960 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree can tepotinib and osimertinib be relied upon for the preservation of human health?

"Our team assessed the safety of tepotinib plus osimertinib to be a 1, owing to its Phase 1 status and limited evidence in regards to efficacy and safety."

Answered by AI

Are there still opportunities to enroll in this research endeavor?

"At the current moment, this research is not looking for participants. Initially published on April 30th 2023 and last updated July 18th 2022, it may still be possible to find other trials related to brain cancer as 408 studies are actively recruiting or 104 if you specifically need treatment with tepotinib plus osimertinib."

Answered by AI

Is this research a groundbreaking endeavor?

"Since 2013, when AstraZeneca first sponsored a study involving 603 patients, tepotinib plus osimertinib has been the focus of ongoing research. This combination drug was eventually approved for Phase 1 & 2 use and is currently part of 104 active trials in over 1000 cities across 51 nations."

Answered by AI

Could you explain what other research has been done on the combination of tepotinib and osimertinib?

"Presently, there are 104 trials in progress studying the effects of tepotinib plus osimertinib. Of those studies, 17 have reached Phase 3 and many are based out of Uniondale New york. Across the world, 4878 sites are running these clinical tests."

Answered by AI

What is the current enrollment for this medical trial?

"Unfortunately, this medical trial is not currently open to recruitment. The research was originally posted on April 30th 2023 and the most recent edition of its listing was made July 18th 2022. For those seeking alternative studies, there are 408 brain cancer trials in progress as well as 104 related to tepotinib plus osimertinib that are actively admitting patients."

Answered by AI
~35 spots leftby Dec 2025