Exelixis has commenced the dose-escalation stage of Phase I clinical trial of its new anti-cancer compound, XL114, as a single agent in non-Hodgkin’s lymphoma (NHL) patients.

XL114 hinders the CARD11-BCL10-MALT1 complex, a vital factor of signalling downstream of B- and T-cell receptors, which boosts the survival and proliferation of B- and T-cell lymphoma. 

Last year, Exelixis exercised the option to in-licence XL114 from Aurigene Discovery Technologies under an option and licence agreement signed by the companies in 2019.

Exelixis is currently in charge of the further clinical development, marketing and worldwide production of XL114.

This first-in-human trial will enrol NHL patients who have already received previous lines of standard therapies. 

Detecting the recommended dose and/or the maximum tolerated dose of XL114 and assessing the safety and initial efficacy of the compound in participants are the trial’s objectives.

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The dose-escalation stage will aid in detecting the recommended dose of XL114 in advanced B- and T-cell NHL patients. 

The cohort-expansion stage will further analyse the safety and preliminary efficacy of XL114 in B-cell NHL-specific expansion cohorts.

These expansion arms will have subjects with activated B-cell-like diffuse large B-cell lymphoma, mantle cell lymphoma and chronic lymphocytic leukaemia/small lymphocytic lymphoma. 

Objective response rate based on lymphoma-specific response criteria as evaluated by the investigator is the primary endpoint of the expansion stage of the trial.

Exelixis Product Development and Medical Affairs executive vice-president and chief medical officer Vicki Goodman said: “The initiation of the dose-escalation stage of our first-in-human Phase I trial of XL114 marks an important milestone in our early efforts to identify treatments for people with blood cancers, such as non-Hodgkin’s lymphoma, who have exhausted known life-prolonging treatment options and are thus facing poor prognoses. 

“Based on preclinical data demonstrating activity in lymphoma cell lines that are resistant to therapies that inhibit Bruton’s tyrosine kinase, we are encouraged by the potential XL114 holds and look forward to advancing to the expansion stage once the appropriate dose is identified.”

In 2019, Exelixis and Roche signed a clinical partnership agreement to carry out three Phase III trials of a combination therapy for cancer.