Clinical Trials

The clinical trial portfolio for AT13148 comprises multiple clinical trials focused on evaluating its therapeutic potential in oncology. Sponsored by Cancer Research UK, these completed Phase I studies investigated the oral administration of this multi-kinase inhibitor in patients with advanced solid tumours. Overall, these initial assessments established the safety, tolerability, and preliminary pharmacokinetics of AT13148 in this patient population.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01585701 COMPLETED
Advanced Solid Tumours
Cancer Research UK
 2012-05 PHASE1
NCT01585701 Completed
Advanced Solid Tumours
Cancer Research UK
 2012-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2018-07-20)

Check the AT13148 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AT13148 functions as an ATP-competitive multi-AGC kinase inhibitor that binds Akt, p70S6K, PKA, and ROCK isoforms, blocking downstream oncogenic phosphorylation and suppressing cancer cell survival pathways. This targeted multi-kinase inhibition ultimately prevents tumor cell proliferation and invasion, supporting its therapeutic application in patients with advanced solid tumours.

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.