Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RMC-5552 · 2 trials · 3 indications
MTD is defined as the maximal dose at which fewer than one-third of participants experience a dose-limiting toxicity (DLT).
RP2D is defined as the selected dose that will be given to participants in Cohorts B and then C. The RP2D will be either the MTD or one dose level lower based on an analysis of the safety data collected in Cohort A, and discussions between the sponsor-investigator and representatives of RevMed.
The frequency of adverse events classified by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 determined to be DLTs will be reported by dose level.
Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) for participants in Cohort A will be summarized by maximum intensity and relationship to study drug.
Median drug levels of RMC-5552 concentration in plasma of participants in Cohort B will be measured on the day of surgery.
Median drug levels of RMC-5552 in tumor tissue of participants in Cohort B will be measured at time of tumor issue removal/surgical resection. The statistical analysis will be descriptive and will be limited to summary statistics for RMC-5552 concentration in tumor (non-enhancing, enhancing, and border).
ORR for participants in Cohort C is defined as the proportion of treated participants with a documented complete response (CR) or partial response (PR) per Response Assessment in Neuro-Oncology (RANO) criteria.
DOR is defined as the time of first documented response to trial therapy (PR or better) until the participants in Cohort C demonstrate disease progression per RANO criteria, initiates subsequent anti-cancer therapy, or completes study participation (whichever occurs first). If disease progression is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the DOR will be censored as the last available disease assessment.
PFS for participants in Cohort C is defined as the time that elapses between cycle 1, day 1 (C1D1) and until the participant experiences disease progression (per RANO criteria), initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever is sooner). If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the PFS will be censored as the last available disease assessment.
OS is defined as the time from C1D1 until the participant completes study follow-up participation, experiences death from any cause or is documented as lost to follow up per institutional standard (whichever is sooner). If death from any cause is not observed prior to completing study participation, the OS will be censored as the time of the last available documentation of survival status.
Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values or vital signs for RMC-5552 monotherapy
Incidence and nature of DLTs with RMC-5552 monotherapy
| Arm | Type | Description |
|---|---|---|
| Cohort A 1(Dose Escalation, Recurrent Non-surgical GBM) | EXPERIMENTAL | 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. |
| Cohort A2 (Dose Escalation, Recurrent Non-surgical GBM) | EXPERIMENTAL | 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. |
| Cohort B (Dose Expansion, Recurrent Surgical GBM) | EXPERIMENTAL | 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. |
| Cohort C (Dose Expansion, Recurrent Non-surgical GBM) | EXPERIMENTAL | Participants will be given the RP2D of RMC-5552 weekly in 21-day cycles until disease progression or unacceptable toxicity |
| RMC-5552 | EXPERIMENTAL | RMC-5552 for IV administration |
| Name | Type | Description |
|---|---|---|
| RMC-5552 | DRUG | Given IV |
Inclusion Criteria: For Cohort A and C (non-surgical): 1. 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 chemothe...
RMC-5552 is an investigational small molecule being studied for the treatment of solid tumors and recurrent glioblastoma. It is currently in Phase 1 clinical development for these oncology indications.
RMC-5552 targets mTORC1 and 4EBP1, which are involved in cell growth and protein synthesis pathways. By inhibiting these targets, the drug aims to disrupt cancer cell proliferation.
RMC-5552 is being developed by Revolution Medicines, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVMD.
RMC-5552 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any use.
RMC-5552 is being studied in two Phase 1 trials. NCT04774952 is a completed dose escalation study in relapsed or refractory solid tumors with 58 participants. NCT05557292 is an ongoing study in recurrent glioblastoma with a target enrollment of 48 participants.
RMC-5552 is also known by its alternative name, RMC-5552. No other alternative names have been reported for this drug.