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mTOR inhibitor

RMC-5552 for Glioblastoma

Phase 1
Recruiting
Led By Nicholas Butowski, MD
Research Sponsored by Nicholas Butowski
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have completed adjuvant radiation therapy at least 12 weeks before starting treatment with RMC-5552
For Cohort B (surgical): Participants must have 1st recurrence of GBM that has recurred or progressed after standard treatment regimen and be a candidate for repeat resection per standard of care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new drug, RMC-5552, to see if it can help treat glioblastoma, a type of brain cancer. The new drug works by preventing the formation of a protein called mTOR, which is involved in cancer cell growth.

Who is the study for?
Adults with a first recurrence of glioblastoma, who've completed standard treatments including radiation and chemotherapy. They must have measurable disease per RANO criteria, adequate organ function, and no major health issues that could interfere with the trial. Participants should not be pregnant or breastfeeding and must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing RMC-5552, an mTOR inhibitor believed to stop cancer cell growth by preventing the formation of mTOR proteins. It's for patients whose glioblastoma has returned after initial treatment. The study will determine the safest dose, side effects, and potential effectiveness.See study design
What are the potential side effects?
Specific side effects are not listed but may include typical reactions to mTOR inhibitors such as mouth sores (stomatitis), high blood sugar levels (hyperglycemia), lung problems like pneumonitis or interstitial lung disease, fatigue, digestive issues, skin rash and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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I finished radiation therapy at least 12 weeks ago.
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My GBM has returned after treatment and I can undergo surgery again.
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My hepatitis B is under control with medication.
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I have a preserved tissue sample from my tumor.
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I had hepatitis C but have been treated and cured.
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I am scheduled for surgery to remove a brain tumor.
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My GBM has come back or worsened after standard treatment.
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My disease can be measured and tracked using specific criteria before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Grade 3 or Higher Adverse Events (Cohort A)
Maximum Tolerated Dose (MTD) (Cohort A)
Median Duration of Response (DOR) (Cohort C)
+7 more
Secondary outcome measures
Area under the plasma concentration time curve (AUC) (Cohort A & C)
Frequency of Grade 3 or Higher Adverse Events (Cohorts B & C)
Median Duration of Response (DOR) (Cohort A)
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort C (Dose Expansion, Recurrent Non-surgical GBM)Experimental Treatment1 Intervention
Participants will be given the RP2D of RMC-5552 weekly in 21-day cycles until disease progression or unacceptable toxicity
Group II: Cohort B (Dose Expansion, Recurrent Surgical GBM)Experimental Treatment1 Intervention
Participants will receive a single dose of RMC-5552 at the RP2D approximately 4 hours prior to participants' scheduled surgical resection as part of standard of care. After recovering from surgery (about 3-6 weeks), participants will continue receiving RMC-5552 weekly in 21-day cycles until disease progression or unacceptable toxicity.
Group III: Cohort A2 (Dose Escalation, Recurrent Non-surgical GBM)Experimental Treatment1 Intervention
Participants receive dose level 2 (12 mg) of RMC-5552 administered intravenously if the toxicity profile from participants in dose level 1 (A1) is acceptable. Participants will receive RMC-5552 weekly in 21-day cycles until disease progression or unacceptable toxicity.
Group IV: Cohort A 1(Dose Escalation, Recurrent Non-surgical GBM)Experimental Treatment1 Intervention
Participants will start at dose level 1 (6 mg) of RMC-5552 administered intravenously. Participants will receive RMC-5552 weekly in 21-day cycles until disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Nicholas ButowskiLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
Revolution Medicines, Inc.Industry Sponsor
10 Previous Clinical Trials
2,014 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,933,171 Total Patients Enrolled
322 Trials studying Glioblastoma
23,067 Patients Enrolled for Glioblastoma

Media Library

Glioblastoma Research Study Groups: Cohort A 1(Dose Escalation, Recurrent Non-surgical GBM), Cohort A2 (Dose Escalation, Recurrent Non-surgical GBM), Cohort B (Dose Expansion, Recurrent Surgical GBM), Cohort C (Dose Expansion, Recurrent Non-surgical GBM)
Glioblastoma Clinical Trial 2023: RMC-5552 Highlights & Side Effects. Trial Name: NCT05557292 β€” Phase 1
RMC-5552 (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557292 β€” Phase 1

Frequently Asked Questions

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

What outcomes is the research team hoping to achieve?

"This 3-year clinical trial's primary objective is to assess the median concentration of RMC-5552 in plasma for Cohort B. Secondary endpoints consist of Area under the Plasma Concentration Time Curve (AUC) for participants in both Cohorts A and C, Median Duration of Response for Cohort A, and Proportion of Participants with detectable levels of pAKT in Tumor Tissue from Cohort B. All pharmacokinetic parameters will be determined through non-compartmental analysis methods while all pharmacodynamic markers shall relate to mTORC1 pathway inhibition assessment within fresh tumour tissue specimens as well as archived"

Answered by AI

Are there any opportunities for prospective participants to join this experiment?

"According to clinicaltrials.gov, this specific medical trial is no longer recruiting participants; however, there are currently 1391 other studies that still require patients. This experiment was first posted on November 1st 2022 and the most recent update occurred at the end of September in the same year."

Answered by AI

Has the Cohort A (Dose Escalation, Recurrent Non-surgical GBM) protocol been accorded clearance by the FDA?

"Our team at Power assigned Cohort A (Dose Escalation, Recurrent Non-surgical GBM) a safety score of 1 due to the limited evidence that exists in Phase 1 trials regarding treatment efficacy and patient safety."

Answered by AI

Who else is applying?

What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

My father is scheduled to have the reoccurring tumour removed this week and would like to be involved in the trail.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma
Nicholas Butowski 2023. "RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05557292.
~30 spots leftby Dec 2025
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