Clinical Trials

Several clinical trials sponsored by Ascentage Pharma Group Inc. are currently recruiting patients to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of APG-2449 as monotherapy and in combination regimens. These active Phase I studies target various advanced malignancies, including non-small cell lung cancer, esophageal cancer, malignant pleural mesothelioma, and platinum-resistant recurrent ovarian cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03917043 RECRUITING
Advanced Solid Cancer; Non Small Cell Lung Cancer; Esophageal Cancer; Ovarian Cancer; Malignant Pleural Mesothelioma
Ascentage Pharma Group Inc.
 2019-05-27 PHASE1
NCT06687070 RECRUITING
Platinum-resistant Recurrent Ovarian Cancer; Advanced Solid Tumor
Ascentage Pharma Group Inc.
 2024-12-17 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-23)

Check the APG-2449 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

APG-2449 functions as an orally active small-molecule inhibitor that selectively targets ALK, ROS1, and focal adhesion kinase (FAK), thereby blocking downstream oncogenic signal transduction and suppressing tumor cell proliferation, survival, and invasive capacity. By disrupting these key driver kinases, the compound exerts potent antiproliferative effects that underpin its clinical evaluation in advanced solid tumors, including non-small-cell lung cancer and platinum-resistant ovarian cancer.

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.