A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors

Key Inclusion Criteria: * Any advanced, unresectable and/or metastatic solid tumors except for primary brain cancer, breast cancer, prostate cancer, pancreatic cancer, pheochromocytoma, fibrolamellar carcinoma, adrenocortical carcinoma, or ocular or cutaneous melanoma. * Must be refractory/relapsed after all standard therapies known to provide proven clinical benefit * ECOG Performance Status 0 to 2 * Adequate organ function as defined by pre-specified laboratory values * Life expectancy \> 3 months * Women of child-bearing potential (or males with female partners of child-bearing potential) must agree to use adequate contraceptive measures throughout the study and for 90 days following last dose Key Exclusion Criteria: * Has not completed appropriate wash-out timeframes of prior anti-cancer treatments * Has ongoing toxicities from prior anti-cancer treatments * Has symptomatic or uncontrolled neurologic disease * Has active and clinically significant bacterial, fungal or viral infection * Cannot avoid use of moderate or strong CYP3A4 inhibitors or inducers; CYP2C19 substrates or OAT2 substrates with narrow therapeutic index; or drugs that prolong the QT interval throughout the study * Has previously received a total anthracycline dose ≥ 360mg/m2 doxorubicin or equivalent * Has a history of serious cardiac conditions or pulmonary or cerebrovascular events within 6 months of first dose * Is pregnant or breastfeeding