Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies

Exclusion Criteria

• •Has persistent clinically significant toxicities (grade \>= 2; per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5) from previous anticancer therapy (excluding alopecia which is permitted and excluding grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, and can be managed with available medical therapies).
• •Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/ interstitial lung disease
• •Has a diagnosis of clinically significant immunodeficiency.
• •Has received external-beam radiation or another systemic anticancer therapy within 14 days or 5 half-lives (whichever is shorter) before start of study treatment.
• •Has received treatment with an investigational drug or monoclonal antibody within 28 days prior to study treatment administration. For classes of investigational agents that are not known to have prolonged toxicities, the washout time may be decreased to 14 days at the discretion of the principal investigator.
• •Has received previous treatment with a histone deacetylase (HDAC) inhibitor.
• •Has an additional active malignancy that may confound the assessment of the study endpoints. Patients with the following concomitant neoplastic diagnoses are eligible: nonmelanoma skin cancer and carcinoma in situ including transitional cell carcinoma, anal carcinoma, and melanoma in situ).
• •Has clinically significant cardiovascular disease including, but not limited to:
• •* Uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure
• •* Uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months before study entry
• •* Clinically significant arrhythmias not controlled by medication.
• •Has a history of untreated brain, or leptomeningeal, metastases (central nervous system (CNS) imaging is not required before study entry unless there is a clinical suspicion of CNS involvement). Subjects with previously treated brain metastases may participate provided:
• •* They are stable (without evidence of progression by imaging for at least four weeks and any neurologic symptoms have returned to baseline)
• •* They have no evidence of new or enlarging brain metastases (confirmed by imaging within 28 days of the first dose of study drug)
• •* They are not using steroids for at least 7 days before the first dose of study drug.
• •This exception does not include leptomeningeal metastases, which is excluded regardless of clinical stability.
• •Has a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before study treatment.
• •Has uncontrolled intercurrent illness including, but not limited to:
• •* Uncontrolled infection
• •* Disseminated intravascular coagulation
• •* Psychiatric illness/social situations that would limit compliance with study requirements.
• •Has known history positive status for human immunodeficiency virus or chronic active hepatitis B or hepatitis C (screening not required).
• •Has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
• •Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug