Clinical Trials

STORM Therapeutics LTD is sponsoring multiple clinical trials evaluating STC-15 in patients with advanced cancer, advanced solid tumors, and specific soft tissue malignancies, including leiomyosarcoma and dedifferentiated liposarcoma. This clinical evaluation comprises a completed Phase 1 trial investigating safety, pharmacokinetics, and pharmacodynamics, alongside an active Phase 1b/2 study currently recruiting patients to assess safety, tolerability, and preliminary antitumor efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06975293 RECRUITING
Solid Tumor; Sarcoma; Leiomyosarcoma; Dedifferentiated Liposarcoma
STORM Therapeutics LTD
 2025-05-05 PHASE1; PHASE2
NCT05584111 COMPLETED
Advanced Cancer; Advanced Solid Tumor; Cancer
STORM Therapeutics LTD
 2022-11-15 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the STC-15 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

STC-15 functions as an oral small-molecule inhibitor of the RNA methyltransferase METTL3, disrupting downstream RNA methylation processes and increasing interferon signaling to activate anti-cancer immune responses. This immune-mediated inhibition of tumor growth and synergistic action with T-cell checkpoint blockade provide the mechanistic foundation for treating advanced malignancies, solid tumors, and sarcomas.

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.