A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Presence of an active hematological malignancy.
• Presence of measurable disease.
• Hematological malignancy has been previously treated, has relapsed after or progressed during prior therapy, and has limited potential for benefit from currently available therapy including hematopoietic stem cell transplantation.
• At least 2 weeks post any treatments/therapies at the time of first dose.
• Adequate bone marrow function.
• Adequate hepatic function.
• Adequate renal function.
• Normal coagulation panel.
• Negative antiviral serology.
• Willingness to use effective contraception.

Exclusion Criteria

• Central nervous system malignancy
• Gastrointestinal disease
• Significant cardiovascular disease
• Significant ECG abnormalities.
• Ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation
• Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
• Pregnancy or breastfeeding.
• Major surgery within 4 weeks before the start of study therapy.
• Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
• Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
• Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.