Clinical Research Directory

Inclusion Criteria: * Has locally advanced or metastatic RCC with predominantly clear cell subtype * Has at least one measurable lesion as defined by RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Has adequate organ function defined as follows: * Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; * Serum creatinine level ≤ 2.0 × upper limit of normal (ULN) * Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease \*Cohort 1: Participants must not have received prior systemic therapy for advanced or metastatic ccRCC * Cohort 2: Participants must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC Exclusion Criteria: * Has received prior treatment with belzutifan or other HIF2α inhibitors * Has received prior treatment with cabozantinib * Has had radiation therapy for bone metastases within two weeks of starting study drug * Has a history of untreated brain metastases or history of leptomeningeal disease or spinal cord compression * Has failed to recover from the reversible effects of prior anticancer therapy * Has uncontrolled or poorly controlled hypertension * Is receiving anticoagulant therapy * Has had any major cardiovascular event within 6 months prior to study drug administration * Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results * Has had major surgery within 3 months before first study drug administration * Has an active infection requiring systemic treatment * Is participating in another therapeutic clinical trial