Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss

Key Inclusion Criteria:

• Has a histologically confirmed, advanced solid tumor that has progressed on priortherapy with an anti-PD-1/L1 inhibitor administered as either monotherapy or incombination with other therapies
• Has documented homozygous CDKN2A loss and Wild-Type TP53
• Confirmation of available tumor tissue collected within 5 years of enrollment
• Measurable tumor lesions per RECIST 1.1
• Estimate life expectancy of at least 6 months
• ECOG PS of 0 or 1
• Resolution of clinically relevant toxic effect of prior anti-cancer therapies Note:AEs from prior therapy must resolve to Grade ≤ 1 per the NCI CTCAE version 5.0, exceptfor peripheral neuropathy, which must resolve to Grade ≤ 2, and alopecia
• Adequate bone marrow, renal and hepatic function

Key Exclusion Criteria:

• Has received prior treatment with any MDM2 inhibitor; prior treatment withatezolizumab is allowed except if the patient discontinued due to toxicity
• Has a history of any Grade 3 or 4 immune-related toxicities to a prior checkpointinhibitor treatment or history of treatment discontinuation with prior checkpointinhibitor use due to toxicity
• Endocrinopathies which are stable with appropriate hormonal supplementationconsistent with other eligibility parameters
• Dermatologic events which have resolved to Grade ≤ 1 on stable medication, asappropriate, and consistent with other eligibility parameters
• Treatment with systemic immunosuppressive medication, including but not limited to,corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, andantitumor necrosis factor agents, within 2 weeks prior to the first dose of studytreatment or anticipation of need for systemic immunosuppressive medication during thecourse of the study
• Has an uncontrolled infection within the 7 days prior to Screening
• Has undergone treatment with therapeutic oral or IV antibiotics within 2 weeks priorto first dose of study treatment
• Has known active central nervous metastases and/or carcinomatous meningitis. Note:Patients who require steroids for brain metastases must be on a stable or taperingdose of corticosteroids for at least 2 weeks before the first dose of study treatment.If applicable, patients must complete stereotactic radiosurgery 7 days before, andspinal or whole brain radiotherapy 21 days before, their first dose of study treatment
• Has as other primary malignancies that have required systemic antineoplastic treatmentwithin 2 years prior to Screening, except for localized cancers that have apparentlybeen cured (eg, nonmelanoma skin cancer, superficial bladder cancer, or carcinoma insitu of the prostate, cervix, or breast) and will not interfere with the studyoutcomes
• Has uncontrolled or significant cardiovascular disease