APTO-253 Clinical Trials

Size	Price	Qty
5mg	USD 269
25mg	USD 807

Clinical Trials

Several Phase 1 clinical trials sponsored by Aptose Biosciences Inc. have evaluated the therapeutic safety and efficacy of APTO-253. These early-stage studies targeted adult and relapsed acute myelogenous leukemia, high-risk myelodysplastic syndromes, and advanced or metastatic solid tumors. Recruitment across these trials encompasses both completed studies in solid tumors and terminated trials in relapsed hematologic malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02267863	TERMINATED	Acute Myelogenous Leukemia in Relapse; Acute Myelogenous Leukemia, Relapsed, Adult; Acute Myelogenous Leukemia, Adult; Acute Myelogenous Leukemia; High Risk Myelodysplasia	Aptose Biosciences Inc.	2014-10	PHASE1
NCT02267863	Terminated	Acute Myelogenous Leukemia in Relapse\|Acute Myelogenous Leukemia Relapsed Adult\|Acute Myelogenous Leukemia Adult\|Acute Myelogenous Leukemia\|High Risk Myelodysplasia	Aptose Biosciences Inc.	2014-10	Phase 1
NCT01281592	Completed	Advanced or Metastatic Solid Tumours	Aptose Biosciences Inc.	2011-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-08-22)

Check the APTO-253 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

APTO-253 acts as a small-molecule inducer of Kruppel-like factor 4 (KLF4) and inhibitor of c-Myc expression, which selectively upregulates CDKN1A (p21) to induce G0-G1 cell-cycle arrest and activate apoptotic pathways in target cells. This target-driven arrest of cellular proliferation and induction of programmed cell death provide the mechanistic basis for its therapeutic evaluation in clinical trials for acute myelogenous leukemia and advanced solid tumors.

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>).