APG-115 in Salivary Gland Cancer Trial

Inclusion Criteria: * Histologically documented malignant salivary gland cancers (including secretory glands of the aerodigestive tract) with or without metastases, not amenable to curative treatment; or there is documentation of patient refusal of curative treatment. * Previous mutational testing with no evidence of a p53 mutation * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Presence of measurable disease by CT scan per RECIST v1.1 with ≥ 20% increase in tumor burden in the preceding 12 months * Life expectancy of ≥12 weeks * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * Patients must be able to take oral medication without breaking/opening, crushing, dissolving, or chewing capsules * Adequate organ and marrow function obtained ≤ 2 weeks prior to enrollment Exclusion Criteria: * Prior treatment with MDM2 inhibitors * Patients are not eligible if they have received any systemic anti-cancer therapy (including chemotherapy and/or hormone therapy) for salivary gland cancer within 4 weeks of the start of study therapy * Patients are not eligible if they have received any of the following within 4 weeks of the start of study therapy: live vaccines, antiretroviral drugs * Progressive disease within 6 months of the last dose of platinum-based chemotherapy * Patients with active brain metastases are excluded because of unknown penetration into the central nervous system (CNS). A confirmatory scan for asymptomatic patients is not required. Patients with a history of treated CNS metastases are eligible provided they meet all of the following criteria: disease outside the CNS is present, no clinical evidence of progression since completion of CNS-directed therapy, minimum 4 weeks between completion of radiotherapy and enrollment, and recovery from significant (Grade ≥ 3) acute toxicity. * A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment * Patients (male and female) having procreative potential who are not willing or not able to use 2 adequate methods of contraception or practicing abstinence during the study and for 90 days following their last dose of treatment * Women who are pregnant or breast-feeding