A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

Exclusion criteria

• ✕. History of any of the following \<=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension \>=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade \>2 (including atrial flutter/ fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
• ✕. QT interval with Fridericia correction method \>450 milliseconds (men) or \>475 milliseconds (women) on a 12- lead ECG during the screening period.
• ✕. Grade \>=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment.
• ✕. Oxygen saturation \<92% on room air at screening or during C1D1 predose assessment.
• ✕. Treatment with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months.
• ✕. Active diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade \>=2 pleural effusion not controlled by tap or requiring indwelling catheters.
• ✕. Grade \>=2 fever of malignant origin.
• ✕. Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus \[HCV\] RNA).