RMC-5552 Clinical Trials

Size	Price	Qty
1mg	USD 597

Clinical Trials

Multiple clinical trials have evaluated RMC-5552 monotherapy in adult oncology settings, including a completed Phase I/Ib dose-escalation study sponsored by Revolution Medicines, Inc. in patients with relapsed or refractory solid tumors. Additionally, a Phase I clinical trial sponsored by Nicholas Butowski evaluated the agent in subjects with glioblastoma and recurrent glioblastoma, though it was terminated. Together, these early-phase evaluations reflect research efforts to assess the safety, tolerability, and preliminary activity of RMC-5552 in advanced malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05557292	TERMINATED	Glioblastoma; Recurrent Glioblastoma	Nicholas Butowski	2023-04-03	PHASE1
NCT04774952	COMPLETED	Solid Tumors	Revolution Medicines, Inc.	2021-04-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the RMC-5552 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RMC-5552 is a potent, selective bi-steric inhibitor of mechanistic target of rapamycin complex 1 (mTORC1) that suppresses the phosphorylation of downstream effectors pS6K and p4EBP1 with IC50 values of 0.14 nM and 0.48 nM, respectively, thereby disrupting cap-dependent protein translation and cell proliferation. By inhibiting hyperactivated mTORC1 signaling driving oncogenic growth, RMC-5552 exhibits therapeutic potential in treating advanced solid tumors and recurrent glioblastoma evaluated across early-phase clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).