A Pilot Study of HIF-Mediated Gene Expression Changes in Casdatifan-Treated Refractory Renal Cell Carcinoma
Vanderbilt-Ingram Cancer Center
Summary
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.
Description
Casdatifan will be provided by Arcus. No additional therapeutic agents will be administered as part of this protocol. 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. Treatment will continue until radiographic disease progression or intolerable toxicity, per protocol-defined discontinuation criteria. Two dose reductions will be permitted in the event of drug-related adverse events, per protocol-defined criteria: * Reduced dose (-1): 50mg once daily * Reduced dose (-2): 25mg once daily Treatment…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugcasdatifan
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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee