Clinical Trials

Multiple clinical trials are currently evaluating NST-628 across oncology indications characterized by MAPK pathway dysregulation. An active, Nested Therapeutics–sponsored Phase 1 trial is recruiting patients with advanced solid tumors harboring RAS, RAF, or MEK mutations—including melanoma, non-small cell lung cancer, and glioma—to evaluate safety, pharmacokinetics, and preliminary efficacy. Additionally, an investigator-sponsored Early Phase 1 trial that is not yet recruiting will assess central nervous system penetration in patients undergoing resection for recurrent grade 4 malignant gliomas.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06326411 RECRUITING
Oncology; MEK Mutation; RAF Gene Mutation; Ras (KRAS or NRAS) Gene Mutation; Melanoma; NSCLC; Glioma; Solid Tumor, Adult; MAPK Pathway Gene Mutation
Nested Therapeutics, Inc
 2024-04-09 PHASE1
NCT07784985 NOT_YET_RECRUITING
Glioma, Recurrent High Grade; Grade 4 Malignant Glioma
Nader Sanai
 2026-10 EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-20)

Check the NST-628 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NST-628 functions as a pan-RAF–MEK molecular glue that binds the RAF–MEK complex to prevent RAF-mediated phosphorylation and activation of MEK, thereby inhibiting downstream mitogen-activated protein kinase (MAPK) signaling and suppressing tumor cell proliferation. By dual-targeting both nodes in the signaling cascade, NST-628 potently impairs oncogenic growth in solid tumors driven by MAPK pathway alterations, including RAS, RAF, or MEK mutations, melanoma, non-small cell lung cancer, and high-grade gliomas currently under clinical investigation.

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>).

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