Exelixis is set to commence a Phase I clinical trial to evaluate XL092 for the treatment of various cancer types.
XL092 is an oral tyrosine kinase inhibitor designed by Exelixis to target VEGF receptors, MET and other kinases related to tumour growth and spread.
The US-based biotechnology firm submitted the compound’s investigational new drug (IND) application to the US Food and Drug Administration (FDA) in December last year.
The multi-centre Phase I trial will assess the safety, tolerability and pharmacokinetics of the drug candidate and will be performed in two sections, consisting of dose-escalation and expansion sections.
Patients suffering from advanced solid tumours will participate in the dose-escalation part.
The primary objective of this portion is to determine a dose for daily oral administration of XL092 that is suitable for further assessment.
Based on the findings from the dose-escalation part of the trial, the expansion portion will be initiated to further study the selected dose in individual tumour cohorts.
The expansion part will evaluate the compound’s safety, tolerability, and initial clinical activity.
Exelixis chief scientific officer and Scientific Strategy executive vice-president Peter Lamb said: “XL092 is a novel compound that targets key signal transduction pathways in tumours, while potentially addressing tumour-induced immune suppression.
“Data from the upcoming Phase II clinical trial will be used to determine the potential for further development of XL092.”
The company partnered with Ipsen in December last year to conduct a Phase III clinical trial (COSMIC-312) of its cabozantinib (cabometyx) therapeutic in combination with atezolizumab (tecentriq) in previously untreated advanced hepatocellular carcinoma (HCC)patients.