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