ASTX-029 Clinical Trials

Size	Price	Qty
5mg	USD 617
25mg	USD 1,790

Clinical Trials

Multiple Phase 1 and Phase 1/2 clinical trials are evaluating ASTX-029 to assess its safety, pharmacokinetics, and efficacy in healthy volunteers and patients with advanced solid tumors, acute myeloid leukemia, or RAS pathway mutant myelodysplastic or myeloproliferative neoplasms. Sponsored by pharmaceutical companies such as Astex Pharmaceuticals, Inc. and Taiho Oncology, Inc., alongside academic institutions including M.D. Anderson Cancer Center, these studies encompass active not recruiting, completed, and withdrawn recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06284460	WITHDRAWN	Pathway Mutant Myelodysplastic Syndromes; Myelodysplastic Neoplasm; Myeloproliferative Neoplasm	M.D. Anderson Cancer Center	2025-01-31	PHASE1; PHASE2
NCT06113289	WITHDRAWN	Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2024-02-08	PHASE1; PHASE2
NCT03520075	COMPLETED	Solid Tumor, Adult	Taiho Oncology, Inc.	2018-05-07	PHASE1; PHASE2
NCT04466514	COMPLETED	Healthy Volunteers	Astex Pharmaceuticals, Inc.	2020-07-23	PHASE1
NCT03520075	Active not recruiting	Solid Tumor Adult	Astex Pharmaceuticals Inc.	2018-05-10	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-02-13)

Check the ASTX-029 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ASTX-029 is an orally bioavailable, selective small-molecule inhibitor that binds to extracellular signal-regulated kinases 1 and 2 (ERK1/2), thereby blocking downstream MAPK signaling cascades and suppressing cancer cell proliferation and survival. By preventing ERK-dependent signaling, ASTX-029 induces tumor cell growth arrest, which underlies its therapeutic development for patients with advanced solid tumors and RAS pathway-mutated malignancies.

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>).