Navicixizumab is being evaluated alone and together with irinotecan in the colorectal cancer arm. Credit: Mikael Häggström, M.D. / commons.wikimedia.org.

OncXerna Therapeutics has dosed the first subject in a Phase II basket trial of navicixizumab in select advanced solid tumour patients.

The multi-centre, open-label, signal finding trial will evaluate the anti-DLL4/VEGF bispecific antibody navicixizumab, alone or along with chemotherapy, in these patients.

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It will have cohorts enrolling colorectal and triple negative breast cancer patients and is open for enrolment at present.

In the colorectal cancer arm, navicixizumab is evaluated alone and together with irinotecan while the triple negative breast cancer cohort is assessing the antibody alone and in combination with paclitaxel.

As per the trial protocol, two additional cohorts have been designed to include ovarian cancer and gastric or gastroesophageal cancer patients.

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These cohorts are expected to be opened in the future.

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The basket trial will also evaluate the potential of OncXerna’s Xerna TME Panel to predict clinical benefits from navicixizumab.

OncXerna CEO Laura Benjamin said: “This Phase II trial is an important milestone for navicixizumab’s development as we seek to build on our promising ovarian cancer data and explore its potential to address unmet needs in other settings, where DLL4 plays a key role in treatment resistance. 

“As part of our company’s commitment to expand precision medicine to improve outcomes for patients, we will also evaluate the potential of the Xerna TME Panel to identify patients more likely to respond to treatment with navicixizumab.”

The Phase II trial will enrol up to 180 patients across the four cohorts.

Progression-free survival and objective response rate are the trial’s primary endpoints.

Duration of response, overall survival, tolerability and safety assessments, and the relationship between the tumour Xerna TME Panel biomarker subtype and the studied regimens’ anti-tumour activity are included as key secondary endpoints.