BioMed Valley Discoveries (BVD) has dosed the first subject in a Phase II clinical trial of ulixertinib (BVD-523) plus hydroxychloroquine (HCQ) in individuals with advanced gastrointestinal malignancies.

The prospective, multicentre, open-label, basket trial will evaluate the efficacy of the combination therapy in advanced gastrointestinal malignancy patients. 

All subjects recruited into the trial should have a mitogen-activated protein kinase (MAPK) activating mutation. 

Each disease-based basket in the trial will be open to subject enrolment in two stages and include gastric, colorectal, oesophageal, pancreatic, and cholangiocarcinomas. 

Being developed as a new anti-cancer drug, ulixertinib is a small molecule, extracellular, signal-regulated kinase (ERK) inhibitor.

It showed encouraging initial efficacy in tumour patients with alterations in the MAPK pathway, the company noted.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

BioMed Valley Discoveries president Brent Kreider said: “Combining an ERK inhibitor with an autophagy inhibitor is anticipated to take advantage of the finding that tumours may become addicted to autophagy for survival in context of MAPK inhibition. 

“Given the favourable safety profile and efficacy seen with ulixertinib monotherapy, we believe that the combination with hydroxychloroquine has the potential to provide significant benefit to patients with advanced gastrointestinal malignancies.”

The latest trial is based on data from the Phase I clinical trial of the combination therapy concluded at the Huntsman Cancer Institute at the University of Utah in the US.

A Phase Ib trial previously assessed ulixertinib monotherapy as a new targeted cancer drug in subject cohorts with mutations in the MAPK pathway. 

According to the trial findings, ulixertinib was found to have an acceptable safety profile. It also showed initial evidence of clinical activity against various RAS/MAPK pathway-driven tumours.