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OncoMatch/Clinical Trials/NCT05557292

RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma

Is NCT05557292 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies RMC-5552 for glioblastoma.

Phase 1RecruitingNicholas ButowskiNCT05557292Data as of May 2026

Treatment: RMC-5552This 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Performance status

ECOG OR KARNOFSKY 0–2

Prior therapy

Must have received: surgery — standard treatment regimen

after standard treatment regimen (surgery and radiotherapy with or without chemotherapy or +/- Tumor treating fields therapy (TTF), +/- concordant investigational agent)

Must have received: radiation therapy — standard treatment regimen

after standard treatment regimen (surgery and radiotherapy with or without chemotherapy or +/- Tumor treating fields therapy (TTF), +/- concordant investigational agent)

Cannot have received: mTOR inhibitor

any prior treatment with anMechanistic target of rapamycin (mTOR) ... inhibitor

Cannot have received: PI3K inhibitor

any prior treatment with ... phosphatidylinositol 3-kinase (PI3K) inhibitor

Lab requirements

Blood counts

Absolute neutrophil count >=1,500/mcL. Platelets >=100,000/mcL.

Kidney function

Creatinine <= 1.5x ULN OR creatinine clearance (GFR) >= 60 mL/min/1.73 m^2 (Cockcroft-Gault), unless safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2.

Liver function

Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. AST <=3x ULN. ALT <=3x ULN.

Cardiac function

LVEF >= institutional lower limit of normal or >= 50%, whichever is lower. No symptomatic CHF (NYHA Class II or higher). No history of congenital long QT syndrome or QTcF > 480 ms (unless pacemaker in place).

Adequate organ function 14 days before starting treatment with RMC-5552 as defined below: Adequate bone marrow function: Absolute neutrophil count >=1,500/mcL. Platelets >=100,000/mcL. Adequate hepatic function: Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. AST <=3 X institutional upper limit of normal. ALT <=3 X institutional upper limit of normal. Adequate renal function: Creatinine <= 1.5 x within institutional upper limit of normal. OR Creatinine clearance (GFR) >= 60 mL/min/1.73 m^2, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California, San Francisco · San Francisco, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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