This is a single-institution, pilot study of oral casdatifan, a selective HIF-2α inhibitor, in patients with metastatic clear cell renal cell carcinoma refractory to prior IO- and VEGF-based therapies. The study will assess changes in HIF2-regulated gene expression through RNA sequencing of serial tumor biopsies obtained at baseline, during treatment, and at progression. Blood samples will also be collected for future analyses.
Signed and dated written informed consent.
Male or female ≥ 18 years of age on the day of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Histologically confirmed metastatic clear cell renal cell carcinoma (ccRCC)
Prior treatment with HIF 2α inhibitors (e.g. belzutifan or related agents)
Is currently participating in or within 2 weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device.
Known severe hypersensitivity (≥ Grade 3) to any of the excipients of casdatifan.
History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart Association [NYHA] functional classification III or IV, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction). History of cerebrovascular accident (including TIA) within the past 6 months (24 weeks) prior to starting study treatment.
Vanderbilt-Ingram Cancer Center
Lead sponsor
Arcus Biosciences, Inc.
Collaborator