RMC-4630 Clinical Trials

Size	Price	Qty
5mg	USD 397
25mg	USD 1,190

Clinical Trials

Several clinical trials are evaluating vociprotafib (RMC-4630) as monotherapy and in combination with ERK or KRAS G12C inhibitors for oncology indications, including advanced solid tumors, non-small cell lung cancer, colorectal cancer, pancreatic cancer, and KRAS-mutated malignancies. Spanning Phase I and Phase II studies, these trials are supported by industry sponsors (Revolution Medicines, Sanofi, Amgen) and institutional collaborators (The Netherlands Cancer Institute, Lustgarten Foundation). Current recruitment statuses across these studies encompass actively recruiting, active but not recruiting, completed, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04185883	ACTIVE_NOT_RECRUITING	Advanced Solid Tumors; Kirsten Rat Sarcoma (KRAS) pG12C Mutation	Amgen	2019-12-17	PHASE1
NCT04916236	TERMINATED	Pancreatic Cancer; Colorectal Cancer; Non-small Cell Lung Cancer; KRAS Mutation-Related Tumors	The Netherlands Cancer Institute	2022-03-31	PHASE1
NCT05054725	COMPLETED	Non-Small Cell Lung Cancer	Revolution Medicines, Inc.	2021-12-30	PHASE2
NCT03634982	UNKNOWN	Solid Tumors	Revolution Medicines, Inc.	2018-09-28	PHASE1
NCT04916236	Recruiting	Pancreatic Cancer\|Colorectal Cancer\|Non-small Cell Lung Cancer\|KRAS Mutation-Related Tumors	The Netherlands Cancer Institute\|Lustgarten Foundation	2022-03-31	Phase 1
NCT03989115	COMPLETED	Solid Tumor	Revolution Medicines, Inc.	2019-07-02	PHASE1; PHASE2
NCT05054725	Active not recruiting	Non-Small Cell Lung Cancer	Revolution Medicines Inc.\|Sanofi\|Amgen	2021-12-30	Phase 2

(data from https://clinicaltrials.gov, updated on 2025-10-22)

Check the RMC-4630 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vociprotafib (RMC-4630) functions as a potent allosteric inhibitor of Src homology 2 domain-containing phosphatase 2 (SHP2), selectively binding the enzyme to block activation of the downstream RAS-RAF-MEK-ERK signaling cascade. This target pathway suppression impairs oncogenic signaling, inhibiting cancer cell proliferation and survival across clinically investigated malignancies such as KRAS-mutated solid tumors, non-small cell lung cancer, colorectal cancer, and pancreatic 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>).