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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

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

Primary study objectives

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 study objectives

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

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: 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.

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