Clinical Trials

Multiple clinical trials sponsored by Revolution Medicines, Inc. are evaluating RMC-6291 (elironrasib) across Phase 1, Phase 1b/2, and Phase 2 protocols. These investigations evaluate monotherapy, combination therapy, and multi-arm platform approaches in advanced KRAS G12C-mutated solid tumors, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. Recruitment statuses across these protocols range from active, not recruiting to actively recruiting patients with stage IV or advanced disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06162221 RECRUITING
Non-Small Cell Lung Cancer, NSCLC; KRAS, NRAS, HRAS-mutated NSCLC; KRAS G12C-mutated Solid Tumors, Lung Cancer; Lung Cancer Stage IV, Advanced Solid Tumor, Cancer; RAS G12D-mutated NSCLC
Revolution Medicines, Inc.
2024-01-18 PHASE1; PHASE2
NCT05462717 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma; Advanced Solid Tumor
Revolution Medicines, Inc.
2022-09-19 PHASE1
NCT06128551 Recruiting
Non-Small Cell Lung Cancer (NSCLC)|Colorectal Cancer|Pancreatic Ductal Adenocarcinoma
Revolution Medicines Inc.
2023-11-14 Phase 1
NCT05462717 Recruiting
Non-Small Cell Lung Cancer (NSCLC)|Colorectal Cancer (CRC)|Pancreatic Ductal Adenocarcinoma|Advanced Solid Tumor
Revolution Medicines Inc.
2022-09-19 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-30)

Check the RMC-6291 (Elironrasib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RMC-6291 is an orally active, covalent inhibitor that forms an intracellular tri-complex with cyclophilin A and GTP-bound KRAS G12C, thereby disrupting downstream oncogenic effector signaling pathways. By suppressing pro-survival MAPK signaling cascades, this agent halts tumor cell proliferation and induces apoptosis, providing a direct therapeutic rational for clinical trial evaluations in KRAS G12C-mutated 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>).

Note: Technical data last updated: Sep 1, 2026.