Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101)

Exclusion criteria

• ✕. Cardiovascular disorders: i. congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, torsades de pointes). ii. uncontrolled hypertension defined as sustained blood pressure \> 150 mmHg systolic or \>90 mm Hg diastolic despite optimal antihypertensive treatment. iii. stroke (including transient ischemic attack \[TIA\]), myocardial infarction, or other ischemic event or pulmonary embolism (PE) within 6 months before first dose. Note: Subjects with a diagnosis of deep vein thrombosis (DVT) within 6 months before first dose are allowed if managed adequately with anticoagulants and asymptomatic at the time of first dose.
• ✕. history of any lower gastrointestinal (GI) disorder (such as inflammatory bowel disease \[IBD\]) or any form of colitis (such as ulcerative colitis or Crohn's disease).
• ✕. history of upper gastrointestinal (GI) inflammatory disorder (eg, esophagitis, gastritis, or duodenitis), gastroparesis, symptomatic gastroesophageal reflux disease (GERD) despite medical therapy, or gastric or duodenal ulcers within 6 months.
• ✕. history of major surgical resection involving the stomach or small bowel or any other reason for a malabsorption syndrome.
• ✕. history of significant bleeding (eg, GI hemorrhage) within 12 weeks before first dose.
• ✕. active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, acute or chronic hepatitis B or C infection, or a known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease. Prophylactic use of antibiotics is allowed.
• ✕. History of COVID-19 unless the subject has clinically recovered from the infection: at least 10 days prior to first dose or sooner, if COVID-19 PCR negative.
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