RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma (NCT05557292) | Clinical Trial Compass
TerminatedPhase 1
RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma
Stopped: Drug no longer provided by sponsor
United States7 participantsStarted 2023-04-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participants must have histologically or cytologically confirmed 1st, 2nd or 3rd recurrence GBM that has recurred or progressed (per standard RANO criteria) after standard treatment regimen (surgery and radiotherapy with or without chemotherapy or +/- Tumor treating fields therapy (TTF), +/- concordant investigational agent).
✓. Participants have confirmed measurable disease per RANO criteria. Participants are eligible after surgery for recurrent disease so long as there is residual enhancing disease and they are deemed medically able to start study treatment within 28 days of the surgical procedure.
✓. Participants must have 1st, 2nd or 3rd recurrence of GBM that has recurred or progressed (per standard RANO criteria) after standard treatment regimen (surgery and radiotherapy with or without chemotherapy) or +/- Tumor treating fields therapy (TTF), +/- concordant investigational agent) and be a candidate for repeat resection per standard of care); that is participants are planning to have routine surgery for resection of recurrent disease.
✓. Confirmed measurable disease per RANO prior to surgical resection.
✓. Archival tissue available in the form of a formalin-fixed paraffin-embedded block (sample derived from the diagnostic tumor). If this is not possible, 20 slides of freshly prepared unstained 4-5 μm sections from the archival tumor block.
✓. Participants must have completed radiation therapy at least 12 weeks before starting treatment with RMC-5552.
What they're measuring
1
Maximum Tolerated Dose (MTD) (Cohort A)
Timeframe: Up to 1 cycle (1 cycle is equal to 21 days)
2
Recommended phase II dose (RP2D) (Cohort A)
Timeframe: Up to 1 cycle (1 cycle is equal to 21 days)
3
Number of Dose-Limiting Toxicities (DLTs) (Cohort A)
Timeframe: Up to 1 cycle (1 cycle is equal to 21 days)
4
Frequency of Grade 3 or Higher Adverse Events (Cohort A)
Timeframe: Up to 1 year after enrollment
5
Median concentration of RMC-5552 in plasma (Cohort B)
Timeframe: At end of infusion & at time of surgery, 1 day
6
Median concentration of RMC-5552 in tumor (Cohort B)
✓. Participants must have completed treatment with chemotherapy or tyrosine kinase/serine/threonine inhibitors at least 2 weeks or 5 half-lives (whichever is longer) before starting treatment with RMC-5552.
✓. Participants must have completed treatment with biologics/monoclonal antibodies, hormonal therapy, and immunotherapy at least 4 weeks before starting treatment with RMC-5552.
Exclusion criteria
✕. Participants has had any prior treatment with anMechanistic target of rapamycin (mTOR) or phosphatidylinositol 3-kinase (PI3K) inhibitor.
✕. Participants with any contraindication to MRI examinations.
✕. Participants with any of the following cardiovascular abnormalities:
✕. Acute coronary syndrome (eg, unstable angina, coronary artery stenting or angioplasty, bypass grafting) within the previous 6 months.
✕. History of or current uncontrolled clinically significant unstable arrhythmias. Note: Participants who have pacemakers to control atrial arrhythmias are candidates for the study. Participants with medically controlled atrial fibrillation \> 1 month prior to first dose of RMC-5552 are eligible.
✕. History of congenital long QT syndrome or prolonged QT interval corrected with Fridericia's method (QTcF) \> 480 ms (unless a pacemaker is in place)
✕. Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or \< 50%, whichever is lower