A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)

Prior treatment

• Has failed to recover from the reversible effects of prior anticancer therapy
• Is receiving warfarin anticoagulant therapy or expected to require warfarin
• Has had any major cardiovascular event within 6 months prior to study drug administration
• Has had major surgery within 4 weeks before first study drug administration
• Has received prior immunotherapy

Other illness

• Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
• Has uncontrolled or poorly controlled hypertension
• 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 known human immunodeficiency virus (HIV) infection
• Has an active infection requiring systemic treatment
• Has any active or recent history of a known or suspected autoimmune disease
  • PART 3 - In addition to PART 1
• Has gastrointestinal (GI) disorders

Lab values

• Has any history of congenital long QT syndrome

Other

• PART 1
• Is participating in another therapeutic clinical trial
  • PART 2 - In addition to PART 1

• PART 1
• Has locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) and has progressed during treatment with at least one prior therapeutic regimen
• Has a life expectancy of ≥ 3 months
• Has adequate organ function
• Able to swallow oral medications
  • PART 2 - In addition to PART 1
• Received no more than three prior systemic treatment regimens in the advanced or metastatic setting
• Must have received at least one but not more than two prior anti-angiogenic therapy regimens
  • PART 3 - In addition to PART 1
• Must have received at least one vascular endothelial growth factor receptor (VEGFR) targeting tyrosine kinase inhibitor