Clinical Trials

Multiple clinical trials sponsored by Astellas Pharma have evaluated the therapeutic potential and oral administration of ASP4132 in patients with advanced cancer, refractory solid tumors, and lymphoma. These open-label Phase I studies utilized dose-escalation and expansion designs to assess the candidate compound. The clinical trials have achieved completed status, yielding preliminary early-phase safety and tolerability data.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02383368 COMPLETED
Lymphoma; Refractory Solid Tumors; Advanced Cancer
Astellas Pharma Global Development, Inc.
 2015-03-23 PHASE1
NCT02383368 Completed
Lymphoma|Refractory Solid Tumors|Advanced Cancer
Astellas Pharma Global Development Inc.|Astellas Pharma Inc
 2015-03-23 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-10-31)

Check the ASP4132 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ASP4132 selectively binds to and activates adenosine monophosphate-activated protein kinase (AMPK), which promotes the phosphorylation of downstream metabolic targets and subsequently downregulates anabolic signaling pathways. This cellular energy regulation suppresses tumor cell proliferation and induces metabolic stress, thereby providing therapeutic rationale for treating advanced refractory solid tumors and lymphoma.

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.