Clinical Trials

Multiple clinical trials evaluate the therapeutic profile of Avitinib (Abivertinib) from Phase I through Phase III across indications including advanced non-small cell lung cancer, B-cell lymphomas, metastatic prostate cancer, and COVID-19. Sponsored by commercial entities such as ACEA Therapeutics and Sorrento Therapeutics alongside clinical research groups, these studies assess safety, pharmacokinetics, and therapeutic efficacy. Recorded trial recruitment statuses encompass completed studies as well as those marked as terminated, suspended, or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05361915 SUSPENDED
Prostate Cancer; Prostate Cancer Metastatic
Sorrento Therapeutics, Inc.
 2025-09 PHASE2
NCT03574402 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Guangdong Association of Clinical Trials
 2018-07-09 PHASE2
NCT03856697 UNKNOWN
Advanced Non-small Cell Lung Cancer
Hangzhou ACEA Pharmaceutical Research Co., Ltd.
 2019-03 PHASE3
NCT04528667 COMPLETED
Covid19
Sorrento Therapeutics, Inc.
 2021-01-06 PHASE2
NCT04440007 COMPLETED
Covid-19
Sorrento Therapeutics, Inc.
 2020-10-09 PHASE2
NCT03060850 Unknown status
B-cell Lymphoma
Hangzhou ACEA Pharmaceutical Research Co. Ltd.
 2017-03-17 Phase 1
NCT03001609 Completed
Carcinoma Non-Small-Cell Lung
Hangzhou ACEA Pharmaceutical Research Co. Ltd.
 2016-11 Phase 1
NCT02448251 Terminated
Non Small Cell Lung Cancer
ACEA Therapeutics Inc.
 2015-05 Phase 1
NCT02274337 Unknown status
Non-Small Cell Lung Cancer
Sun Yat-sen University|Acea Bio (Hangzhou) Co. Ltd.|Hangzhou ACEA Pharmaceutical Research Co. Ltd.
 2014-09 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-03-18)

Check the Avitinib (Abivertinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Avitinib functions as a pyrrolopyrimidine-derived irreversible inhibitor that selectively binds mutant epidermal growth factor receptor (EGFR L858R/T790M), thereby blocking receptor autophosphorylation and downstream pro-survival signaling pathways. This targeted suppression of aberrant kinase activity inhibits cellular proliferation and triggers apoptosis, suppressing tumor growth in clinical trial settings such as non-small cell lung 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.