Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
Study NCT ID:
NCT05557292
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2022-09-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma
Sponsor:
Nicholas Butowski
Organization:
Study Overview
Official Title:
A Phase I/Ib, Open-Label, Dose-Escalation Study of RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of mTORC1 kinase inhibitor RMC-5552 (RMC- 5552). (Cohort A).
II. To characterize the safety and tolerability of RMC-5552 monotherapy. (Cohort A).
III. To characterize the pharmacokinetics (PK) of RMC-5552 after a single dose of RMC-5552 prior to surgical resection. (Cohort B).
IV. To evaluate the preliminary antitumor effect of RMC-5552. (Cohort C).
SECONDARY OBJECTIVES:
I. To measure the pharmacokinetics (PK) of RMC-5552. (Cohort A). II. To evaluate the preliminary antitumor effect of RMC-5552. (Cohort A). III. To assess pharmacodynamic (PD) markers of drug activity, including biochemical markers of mTORC1 pathway inhibition in tumor tissue. (Cohort B).
IV. To characterize the safety and tolerability of RMC-5552 monotherapy. (Cohort B).
V. To evaluate the preliminary antitumor effect of RMC-5552 in recurrent glioblastoma multiforme (GBM). (Cohort B).
VI. To characterize the safety and tolerability of RMC-5552 monotherapy. (Cohort C).
VII. To measure the PK of RMC-5552. (Cohort C).
OUTLINE: This is a phase I, dose-escalation study (Cohort A) followed by a phase Ib study (Cohorts B and C). Participants are assigned to 1 of 3 cohorts.
COHORT A: Non-surgical patients receive RMC-5552 intravenously (IV) on study. Patients undergo a pulmonary function test and chest x-ray during screening. Patients also undergo a brain magnetic resonance imaging (MRI) throughout the trial. Patents undergo blood sample collection on study.
\*\*\* Participants will be enrolled concurrently in Cohorts B and C \*\*\*
COHORT B: Surgical patients receive a single dose of RP2D RMC-5552 IV prior to standard of care surgery and then on study. Patients undergo a pulmonary function test and chest x-ray during screening. Patients also undergo a brain MRI throughout the trial. Patents undergo blood sample collection on study.
COHORT C: Non-surgical patients receive RP2D of RMC-5552 IV on study. Patients undergo a pulmonary function test and chest x-ray during screening. Patients also undergo a brain MRI throughout the trial. Patents undergo blood sample collection on study.
Participants will be followed after their last treatment with RMC-5552 until the participant voluntarily withdraws consent, or until death; whichever comes first.
I. To determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of mTORC1 kinase inhibitor RMC-5552 (RMC- 5552). (Cohort A).
II. To characterize the safety and tolerability of RMC-5552 monotherapy. (Cohort A).
III. To characterize the pharmacokinetics (PK) of RMC-5552 after a single dose of RMC-5552 prior to surgical resection. (Cohort B).
IV. To evaluate the preliminary antitumor effect of RMC-5552. (Cohort C).
SECONDARY OBJECTIVES:
I. To measure the pharmacokinetics (PK) of RMC-5552. (Cohort A). II. To evaluate the preliminary antitumor effect of RMC-5552. (Cohort A). III. To assess pharmacodynamic (PD) markers of drug activity, including biochemical markers of mTORC1 pathway inhibition in tumor tissue. (Cohort B).
IV. To characterize the safety and tolerability of RMC-5552 monotherapy. (Cohort B).
V. To evaluate the preliminary antitumor effect of RMC-5552 in recurrent glioblastoma multiforme (GBM). (Cohort B).
VI. To characterize the safety and tolerability of RMC-5552 monotherapy. (Cohort C).
VII. To measure the PK of RMC-5552. (Cohort C).
OUTLINE: This is a phase I, dose-escalation study (Cohort A) followed by a phase Ib study (Cohorts B and C). Participants are assigned to 1 of 3 cohorts.
COHORT A: Non-surgical patients receive RMC-5552 intravenously (IV) on study. Patients undergo a pulmonary function test and chest x-ray during screening. Patients also undergo a brain magnetic resonance imaging (MRI) throughout the trial. Patents undergo blood sample collection on study.
\*\*\* Participants will be enrolled concurrently in Cohorts B and C \*\*\*
COHORT B: Surgical patients receive a single dose of RP2D RMC-5552 IV prior to standard of care surgery and then on study. Patients undergo a pulmonary function test and chest x-ray during screening. Patients also undergo a brain MRI throughout the trial. Patents undergo blood sample collection on study.
COHORT C: Non-surgical patients receive RP2D of RMC-5552 IV on study. Patients undergo a pulmonary function test and chest x-ray during screening. Patients also undergo a brain MRI throughout the trial. Patents undergo blood sample collection on study.
Participants will be followed after their last treatment with RMC-5552 until the participant voluntarily withdraws consent, or until death; whichever comes first.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-07698 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View | |
| P50CA097257 | NIH | None | https://reporter.nih.gov/quic… | View |