48 Participants Needed

RMC-5552 for Glioblastoma

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Overseen ByNeuro-Oncology New Patient Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/Ib trial tests the side effects, best dose, tolerability, and effectiveness of RMC-5552 in treating patients with glioblastoma that has come back (recurrent). RMC-5552 is a type of medicine called an mechanistic target of rapamycin (mTOR) inhibitor. These types of drugs prevent the formation of a specific group of proteins called mTOR. This protein controls cancer cell growth, and the study doctors believe stopping mTOR from forming may help to kill tumor cells.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop certain medications before joining the trial. You must complete chemotherapy or specific inhibitors at least 2 weeks or 5 half-lives before starting, and biologics, hormonal therapy, and immunotherapy at least 4 weeks before starting the trial. There are also specific requirements for nitrosourea and mitomycin C, which must be stopped 6 weeks before the trial.

What makes the drug RMC-5552 unique for treating glioblastoma?

RMC-5552 is unique because it targets specific molecular pathways in glioblastoma that are not effectively addressed by standard treatments, which typically involve surgery, chemotherapy, and radiation. This drug may offer a novel approach by focusing on molecular targets that contribute to the resistance seen in traditional therapies.12345

Who Is on the Research Team?

Dr. Nicholas Butowski | UCSF Health

Nicholas Butowski, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I finished my chemotherapy or tyrosine kinase inhibitor treatment at least 2 weeks ago.
I finished radiation therapy at least 12 weeks ago.
Participants must have confirmed measurable disease per RANO criteria
See 14 more

Exclusion Criteria

I still have side effects from previous cancer treatments.
I have not had a stroke or mini-stroke in the past 6 months.
I have previously been treated with an mTOR or PI3K inhibitor.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Dose Escalation

Non-surgical patients receive RMC-5552 intravenously in 21-day cycles to determine the maximum tolerated dose

Up to 1 cycle (21 days)
Weekly visits for drug administration

Dose Expansion

Surgical patients receive a single dose of RMC-5552 prior to surgery, followed by weekly doses post-surgery in 21-day cycles

3-6 weeks post-surgery recovery, then ongoing
Pre-surgery and weekly post-surgery visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • RMC-5552
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Cohort C (Dose Expansion, Recurrent Non-surgical GBM)Experimental Treatment1 Intervention
Group II: Cohort B (Dose Expansion, Recurrent Surgical GBM)Experimental Treatment1 Intervention
Group III: Cohort A2 (Dose Escalation, Recurrent Non-surgical GBM)Experimental Treatment1 Intervention
Group IV: Cohort A 1(Dose Escalation, Recurrent Non-surgical GBM)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nicholas Butowski

Lead Sponsor

Trials
3
Recruited
130+

Revolution Medicines, Inc.

Industry Sponsor

Trials
14
Recruited
4,500+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Current standard treatment for glioblastoma, which includes surgery and temozolomide, results in a median survival of only 12-14 months, highlighting the urgent need for new therapies.
Recent studies on targeted agents like bevacizumab show potential clinical benefits, and ongoing research is exploring various molecular targets and inhibitors to improve treatment outcomes for glioblastoma patients.
Pathway inhibition: emerging molecular targets for treating glioblastoma.Wick, W., Weller, M., Weiler, M., et al.[2022]
An atypical protein kinase C inhibitor was found to induce rapid apoptosis in glioblastoma cells expressing the mutant EGFRvIII, with an effective concentration (IC50) of 16 microM.
The apoptosis caused by this inhibitor occurs through a caspase-independent mechanism, suggesting a novel pathway for targeting glioblastoma cells that are resistant to standard chemotherapy.
Induction of apoptosis in glioblastoma cells by an atypical protein kinase C pseudosubstrate peptide.Lorimer, IA., Parolin, DA., Lavictoire, SJ.[2018]
In a phase II trial involving 56 patients with recurrent glioblastoma (GBM) enriched for EGFR gene amplification, dacomitinib showed effective penetration into tumors, but only 14.3% of patients experienced a clinical benefit lasting at least 6 months.
The presence of specific EGFR mutations (EGFRvIII or EGFR ECD missense mutations) did not predict clinical benefit from dacomitinib, suggesting that alternative biomarkers, such as RNA signatures in circulating extracellular vesicles, may be more promising for identifying patients who could respond to treatment.
Exploring Predictors of Response to Dacomitinib in EGFR-Amplified Recurrent Glioblastoma.Chi, AS., Cahill, DP., Reardon, DA., et al.[2021]

Citations

Pathway inhibition: emerging molecular targets for treating glioblastoma. [2022]
Induction of apoptosis in glioblastoma cells by an atypical protein kinase C pseudosubstrate peptide. [2018]
Exploring Predictors of Response to Dacomitinib in EGFR-Amplified Recurrent Glioblastoma. [2021]
Phase II trial of dacomitinib, a pan-human EGFR tyrosine kinase inhibitor, in recurrent glioblastoma patients with EGFR amplification. [2022]
A multicenter, phase II trial of GC1118, a novel anti-EGFR antibody, for recurrent glioblastoma patients with EGFR amplification. [2023]
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