Clinical Trials

Daraxonrasib (RMC-6236) is currently evaluated in several clinical trials targeting RAS-mutated malignancies, primarily advanced solid tumors including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer. Spanning early-phase evaluations to pivotal late-stage studies, these clinical investigations encompass both actively recruiting and active, non-recruiting protocols. Key industry sponsors driving these evaluations include Revolution Medicines, Inc., Amgen, and Tango Therapeutics, Inc.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06881784 RECRUITING
NSCLC (Non-small Cell Lung Cancer); Non-Small Cell Lung Cancer; NSCLC; NSCLC (Non-small Cell Lung Carcinoma); NSCLC (Advanced Non-small Cell Lung Cancer)
Revolution Medicines, Inc.
2025-05-06 PHASE3
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
NCT06922591 RECRUITING
PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; NSCLC; RAS Mutation; MTAP Deletion; Lung Cancer; Pancreatic Cancer Metastatic; Thoracic Cancer
Tango Therapeutics, Inc.
2025-05-31 PHASE1; PHASE2
NCT05379985 RECRUITING
Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Advanced Solid Tumors
Revolution Medicines, Inc.
2022-05-31 PHASE1; PHASE2
NCT06445062 RECRUITING
Colorectal Cancer; CRC; Pancreatic Ductal Adenocarcinoma; PDAC; Gastrointestinal Cancer; Metastatic Pancreatic Ductal Adenocarcinoma
Revolution Medicines, Inc.
2024-05-24 PHASE1; PHASE2
NCT06040541 RECRUITING
Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Advanced Solid Tumors
Revolution Medicines, Inc.
2023-09-07 PHASE1
NCT06360354 ACTIVE_NOT_RECRUITING
Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers
Amgen
2024-05-29 PHASE1
NCT06625320 ACTIVE_NOT_RECRUITING
Pancreatic Cancer; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma
Revolution Medicines, Inc.
2024-10-16 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-27)

Check the Daraxonrasib (RMC-6236) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Daraxonrasib (RMC-6236) selectively binds to the active, GTP-bound state of canonical RAS isoforms, blocking downstream effector pathway signaling and suppressing proliferation in RAS-dependent tumor cells. By disrupting oncogenic RAS(ON) signaling complexes, it halts cell cycle progression and tumor growth, providing therapeutic relevance for treating RAS-mutated solid tumors, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer.

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.