Aravive (NASDAQ:ARAV) dosed the first patient in the Phase 2 portion of a Phase 1b/2 study of batiraxcept for the treatment of clear cell renal cell carcinoma (ccRCC).
“Safety and preliminary activity data from the Phase 1b study of batiraxcept in combination with cabozantinib in patients with 2L+ ccRCC gives us confidence to initiate the Phase 2 portion of the trial and expand the study to additional cohorts,” Gail McIntyre, Ph.D. and CEO of Aravive, said in a statement.
“The data reported to date show clinically relevant benefit of adding batiraxcept to the current standard of care in ccRCC without adding to the toxicity profile,” she added. Clinical activity and safety updates of the Phase 2 portion of the study will be updated throughout 2022.
Aravive expects to enroll 55 patients in three parts of the Phase 2 open-label portion of the Phase 1b/2 clinical trial of batiraxcept in ccRCC. The primary endpoint of each part of the Phase 2 portion of the trial is objective response rate and key secondary endpoints include duration of response, progression free survival, and overall survival.
