Date: 2017-10-19
Type of
information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: BergenBio (Norway)
Product: bemcentinib (BGB324)
Action
mechanism:
- AXL inhibitor/ receptor tyrosine kinase inhibitor. BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase that blocks the epithelial-mesenchymal transition, which is a key driver of metastasis and drug-resistance.. Preclinical in vivo studies have shown that BGB324 has both single agent activity in leukemia and solid tumors and is very effective in preventing and reversing acquired resistance to existing therapies including cytotoxics, protein kinase inhibitors and other targeted therapies.
Disease: previously treated, locally advanced and unresectable or metastatic triple-negative breast cancer (TNBC) or triple negative inflammatory breast cancer (TN-IBC)
Therapeutic
area: Cancer - Oncology
Country: Norway, Spain, UK, USA
Trial
details:
- This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in up to 56 patients with previously treated, locally advanced and unresectable, or metastatic TNBC or TN-IBC. The study will utilise an extension of Simon's 2-stage design. The primary objective is objective response rate. (NCT03184558)
Latest
news:
- • On October 19, 2017, BerGenBio announced that the first patient has been dosed in a Phase II trial evaluating the Company’s lead product BGB324 in combination with Keytruda® (pembrolizumab) in patients with previously treated, locally advanced and unresectable or metastatic triple-negative breast cancer (TNBC) or triple negative inflammatory breast cancer (TN-IBC). The trial is being sponsored by BerGenBio. Merck & Co will supply Keytruda® for use in the study under a collaboration agreement signed between the two companies in March 2017. The trial plans to enrol up to 56 patients in hospitals in Norway, Spain, the UK and the US.
The clinical study will primarily evaluate the anti-tumour activity, objective response rate, and safety profile of the combination. Additionally, the study will assess the pharmacokinetic profile of BGB324 when given with Keytruda® . Comprehensive exploratory studies will evaluate biomarkers in tumour and blood indicative of immune modulation and Axl signalling, including expression levels of PD-L1 and Axl. The trial is expected to deliver preliminary results at the end of 2018.
Is
general: Yes
