An Open-label, Phase I, Dose Escalation Trial of Methionine Aminopeptidase 2 Inhibitor M8891 in Subjects with Advanced Solid Tumors (sponsor protocol MS100015-0019)
Johns Hopkins Kimmel Cancer Center in Baltimore
To determine the maximum tolerated dose (MTD) of M8891 as a single agent in subjects with solid tumors. To evaluate the safety profile and tolerability of M8891. To assess the antitumor activity of M8891 as a single agent. To determine the recommended Phase II dose.
Patients must be refractory to or intolerant to existing cancer therapies known to provide clinical benefit. Patients must have had at least 1 prior systemic anticancer therapy. Patients must be at least 18 years old. All patients of child bearing potential must use study approved contraceptives. Patients must agree to 2 tumor biopsies. Good performance status, with a life expectancy of greater than 3 months. Patients must have normal organ and marrow function as defined by study lab parameters. NO bone marrow or stem cell transplant within past 5 years or extensive radiation to bone marrow reserves. NO history of stroke, heart attack, thrombosis within 6 months. NO clinically significant cardiac conduction abnormalities. NO pregnant or nursing females. NO participation in another clinical trial in past 28 days. NO history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease or conditions. NO ongoing intercurrent illness that would limit compliance with study requirements. NO history of allergies to trial treatment drug.
Treatment will be administered on an outpatient basis. Patients will take M8891 drug orally daily at home. Patient will be assessed in clinic on Days 1,2,4,8,15,16 of Cycle 1 (each cycle is 28 days); Day 1,8,15 of Cycle 2; and Day 1 of each cycle after. Patients will receive study drug treatment until disease progression, unacceptable toxicity, withdrawal of consent, or intercurrent illness which prevents study drug administration.
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