The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation

Open to people ages 12 years and up

• At least 18 years of age or 12 to 17 years of age after adequate adult safety data become available
• Advanced solid malignancy with a p53 Y220C mutation
• Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
• Previously treated with one or more lines of anticancer therapy and progressive disease
• Adequate organ function

• Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug
• Radiotherapy within 28 days of receiving the study drug
• Primary CNS tumor (Phase 1, Phase 2 Cohort A)
• History of leptomeningeal disease or spinal cord compression
• Brain metastases, unless asymptomatic and not requiring steroids for at least 2 weeks prior to receiving the study drug
• Stroke or transient ischemic attack within 6 months prior to screening
• Heart conditions such as unstable angina, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities
• Strong CYP3A4 inhibitors or inducers, medications with a known risk of QT/QTc prolongation, or proton pump inhibitors
• History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication
• History of prior organ transplant
• Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer
• Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection