Vanderbilt-Ingram Cancer Center
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. This phase I trial evaluates the effects of casdatifan on certain genes linked to kidney cancer growth and tests it for the treatment of clear cell renal cell cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Casdatifan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE: I. To determine the change in expression of predefined HIF2-regulated target genes in metastatic tumor tissue following casdatifan therapy in a refractory clear cell renal cell carcinoma (ccRCC) population. SECONDARY OBJECTIVES: I. To assess changes in global tumor gene expression following casdatifan treatment. II. To identify differences in baseline and on-treatment HIF-mediated gene expression between objective responders and non-responders. OUTLINE: Patients receive casdatifan orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in th…
Inclusion Criteria: 1. Signed and dated written informed consent. 2. Male or female ≥ 18 years of age on the day of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 4. Histologically confirmed metastatic clear cell renal cell carcinoma (ccRCC) 5. Patients must have received at least one immune oncology (IO) agent and at least one VEGF-targeted therapy (alone or in combination) 6. Measurable tumor burden which can be followed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST 1.1 as assessed by the local site in…
Casdatifan will be taken orally at a fixed dose of 100 mg once daily, with or without food, on a continuous schedule beginning on Cycle 1, Day 1.
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