Aravive has announced the dosing of the first subject in the Phase II segment of a Phase Ib/II clinical trial of batiraxcept (AVB-500) to treat clear cell renal cell carcinoma (ccRCC).  

Initial top-line results from the trial are expected throughout this year.

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The open-label Phase II trial of batiraxcept plans to enrol 55 ccRCC patients across three parts. 

Anticipated to have nearly 25 subjects, Part A will assess 15mg/kg batiraxcept plus cabozantinib in ccRCC patients in at least the second-line setting. 

Part B is planned to have nearly 20 first-line ccRCC patients and will analyse 15mg/kg batiraxcept plus standard of care involving nivolumab and cabozantinib. 

Furthermore, Part C will assess 15mg/kg batiraxcept as monotherapy in nearly ten individuals with ccRCC, who are not eligible for curative intent treatments. 

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Objective response rate is the primary endpoint of each part of the Phase II portion while the duration of response, progression-free survival, and overall survival will be included as key secondary endpoints.

Aravive CEO Gail McIntyre said: “Safety and preliminary activity data from the Phase Ib study of batiraxcept in combination with cabozantinib in patients with 2L+ ccRCC gives us confidence to initiate the Phase II portion of the trial and expand the study to additional cohorts. 

“The data reported to date shows clinically relevant benefit of adding batiraxcept to the current standard of care in ccRCC without adding to the toxicity profile. 

“We will continue to update the ongoing Phase Ib portion of the study as data mature and anticipate providing clinical activity and safety updates of the P2 portion of the study throughout 2022.”

A therapeutic recombinant fusion protein, batiraxcept demonstrated to neutralise Growth Arrest Specific 6 (GAS6) activity by attaching to GAS6 with greater affinity in preclinical models. 

Batiraxcept does so by specifically hindering the GAS6-AXL signalling pathway, which is upregulated in several types of cancers including ovarian, renal and pancreatic. 

Aravive started the Phase Ib portion of a trial assessing AVB-S6-500 plus standard-of-care to treat platinum-resistant recurrent ovarian cancer, in December 2018.