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)
Mechanism and Biochemical Profile
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>).
- RMC-6291 (Elironrasib) Solubility in DMSO
- RMC-6291 (Elironrasib) Stock Solution
- RMC-6291 (Elironrasib) Storage
- RMC-6291 (Elironrasib) Stability
- RMC-6291 (Elironrasib) Molecular Weight
- RMC-6291 (Elironrasib) CAS Number
- RMC-6291 (Elironrasib) Chemical Structure (2D and 3D)
- RMC-6291 (Elironrasib) SDS|MSDS