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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
RMC-5552 is an investigational small molecule developed by Revolution Medicines, Inc. for the treatment of cancer. It is being studied in Phase 1 clinical trials in adults with recurrent glioblastoma and in relapsed or refractory solid tumors. It is not approved for any indication and remains in clinical development.
RMC-5552 is being evaluated for the treatment of recurrent glioblastoma and relapsed or refractory solid tumors. Both are oncology indications studied in Phase 1 trials in adult patients. The drug is investigational and has not been approved for any use.
RMC-5552 targets mTORC1 and 4EBP1. It is a small molecule designed to act on this pathway, which is relevant to tumor cell growth and survival. This mechanism underlies its study in glioblastoma and solid tumor settings.
RMC-5552 is developed by Revolution Medicines, Inc., a biotechnology company that trades under the ticker RVMD. The company is the sponsor of the clinical program evaluating the drug in recurrent glioblastoma and relapsed or refractory solid tumors.
RMC-5552 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The program includes a completed dose escalation study in solid tumors and an ongoing Phase 1 study in recurrent glioblastoma.
RMC-5552 has been studied in two Phase 1 trials. NCT04774952 evaluated dose escalation in relapsed or refractory solid tumors and is completed, with 58 participants. NCT05557292 is a recruiting Phase 1 monotherapy trial in adults with recurrent glioblastoma, with a planned enrollment of 48.