Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Advanced Non Small Cell Lung Cancer
Summary
AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate Capsules has three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress the EGFR mutant tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient suppress the EGFR T790M drug-resistant mutation tumor cell.
Timeline
- Start
- 2014-09
- Primary completion
- 2017-06
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abivertinib | Small molecule | 50 mg | Oral |
| Subject | Abivertinib | Small molecule | 100 mg | Oral |
| Subject | Abivertinib | Small molecule | 200 mg | Oral |
| Subject | Abivertinib | Small molecule | 350 mg | Oral |
| Subject | Abivertinib | Small molecule | 550 mg | Oral |
| Subject | Abivertinib | Small molecule | 850 mg | Oral |
| Subject | Abivertinib | Small molecule | 1100 mg | Oral |