RMC-5127 Clinical Trials

Size	Price	Qty
1mg	USD 497

Clinical Trials

A Phase 1/1b open-label, multicenter clinical trial sponsored by Revolution Medicines, Inc., is actively recruiting participants to evaluate RMC5127 in patients with advanced solid tumors. The study assesses the safety, pharmacokinetics, and clinical efficacy of the compound in KRAS G12V-mutant malignancies, specifically non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. This initial investigation marks the ongoing clinical evaluation of RMC5127 across these targeted oncological indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07349537	RECRUITING	Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); PDAC; CRC; NSCLC; Pancreatic Cancer; Lung Cancer (NSCLC); Advanced Solid Tumors	Revolution Medicines, Inc.	2026-01-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-10)

Check the RMC-5127 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RMC5127 non-covalently binds cyclophilin A to form a binary complex that selectively engages GTP-bound RAS G12V, creating a high-affinity tri-complex that sterically blocks downstream effector binding and potently suppresses oncogenic RAS signaling. This targeted pathway inhibition suppresses tumor cell growth and survival, providing anti-tumor activity relevant to clinical trial conditions such as KRAS G12V-mutant non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

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>).