BTM-3566 in Advanced Solid Tumors

This study is a phase 1, open label, dose escalation study using single participant cohorts followed by 3+3 design to evaluate multiple ascending doses of BTM-3566.

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