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 wi…