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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

1906 - BPI-9016M, a novel c-Met inhibitor, in pretreated advanced solid tumor: results from a first-in-human, phase 1, dose-escalation study

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Xingsheng Hu

Citation

Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292

Authors

X. Hu1, X. Zheng2, H. Mo1, X. Cui2, L. Ding3, F. Tan4, P. Hu2, Y. Shi1

Author affiliations

  • 1 Department Of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, 100021 - Beijing/CN
  • 2 Clinical Pharmacology Research Center, Peking Union Medical College Hospital, 100032 - Beijing/CN
  • 3 Headquarter, Bettapharma Pharmaceuticals Co.Ltd, 311100 - Hangzhou/CN
  • 4 R&d Center, Bettapharma Pharmaceuticals Co.Ltd, 100176 - Beijing/CN
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Resources

Abstract 1906

Background

BPI-9016M (Betta Pharmaceuticals Co, Ltd, Hangzhou, China) is a potent targeted therapy that inhibits MET and Axl. This first-in-human study is to assess the safety, tolerability, and pharmacokinetics (PK) of BPI-9016M in patients with advanced solid tumor, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the phase Ib/II study.

Methods

Method: Eligible patients were enrolled into sequential dose-escalating cohorts from 100 mg to 1000 mg given orally once per day continually following the conventional 3 + 3 design. The primary endpoint was safety and tolerability. MTD was defined as the highest dose level resulting in < 1 of 3 dose limiting toxicities (DLTs). Blood levels of BPI-9016M were evaluated after single and multiple administration (NCT02478866).

Results

Twenty patients were enrolled and treated in 6 of 7 predefined dose cohorts (100 mg n = 4, 200 mg n = 3, 300 mg n = 3, 450 mg n = 4, 600 mg n = 3, 800 mg n = 3), dose escalation stopped at 800 mg due to saturation. All had stage IV non-small cell lung cancer (NSCLC) progressed on previous systemic therapy (including previous EGFR TKI in 16 patients). BPI-9016M was well-tolerated in all dose cohorts without DLT. The incidence of overall and grade 3/4 TRAEs was 85% and 45%, respectively. Common TRAEs included elevated ALT (45%), constipation (30%), elevated bilirubin (25%), and oral paresthesia (25%). Tumor response was seen in 1 patients in the 800 mg dose cohort. Systemic exposure to BPI-9016M (maximum plasma concentration and AUC) increased with increasing dose. Mean time to maximum plasma concentration and half-life were 2 to 5.33 hours and 8.09 to 22.3 hours, respectively. Two metabolites (M1, M2-2) were detected.

Conclusions

BPI-9016M was well tolerated in patients with advanced solid tumor. A phase Ib study is ongoing to investigate the safety and activity of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC (NCT02929290).

Clinical trial identification

NCT02478866.

Legal entity responsible for the study

Bettapharma Pharmaceuticals Co.Ltd.

Funding

Bettapharma Pharmaceuticals Co.Ltd.

Editorial Acknowledgement

NA

Disclosure

L. Ding: Stock owner, leadership, and full-time employee: Bettapharma Pharmaceuticals Co. Ltd. F. Tan: Stock owner: Bettapharma Pharmaceuticals Co. Ltd. All other authors have declared no conflicts of interest.

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