Clinical Trials

Metarrestin is currently being evaluated in multiple clinical trials focused on refractory and advanced malignancies. These Phase I investigations assess the safety, tolerability, pharmacokinetics, and preliminary therapeutic activity of the compound in conditions such as advanced solid tumors, metastatic pancreatic cancer, pediatric solid tumors, advanced breast cancer, malignant peripheral nerve sheath tumors, and colorectal neoplasms. Sponsored by public research institutions including the National Cancer Institute and the National Institutes of Health Clinical Center, these studies are actively recruiting to evaluate first-in-human clinical outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04222413 RECRUITING
Advanced Solid Tumors; Metastatic Pancreatic Cancer; Pediatric Solid Tumor; Advanced Breast Cancer; Malignant Peripheral Nerve Sheath Tumor; Colorectal Neoplasms
National Cancer Institute (NCI)
 2020-10-27 PHASE1
NCT04222413 Recruiting
Advanced Solid Tumors|Metastatic Pancreatic Cancer|Pediatric Solid Tumor|Advanced Breast Cancer|Malignant Peripheral Nerve Sheath Tumor|Colorectal Neoplasms
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2020-10-27 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metarrestin selectively disassembles the perinucleolar compartment, leading to the disruption of nucleolar structural integrity and the downstream inhibition of RNA polymerase I-mediated transcription. By suppressing nucleolar function and blocking metastatic development in malignant cells, this pathway inhibition provides a compelling mechanistic basis for its ongoing evaluation in patients with advanced solid tumors, metastatic pancreatic cancer, and colorectal neoplasms.

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.