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

Inclusion Criteria

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

Exclusion Criteria

PART 1

Has a history of untreated brain metastasis 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 warfarin anticoagulant therapy or expected to require warfarin
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 4 weeks before first study drug administration
Has known human immunodeficiency virus (HIV) infection
Has an active infection requiring systemic treatment
Is participating in another therapeutic clinical trial

PART 2 - In addition to PART 1

Has received prior immunotherapy
Has any active or recent history of a known or suspected autoimmune disease

PART 3 - In addition to PART 1

Has gastrointestinal (GI) disorders
Has any history of congenital long QT syndrome