A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer

Inclusion Criteria

• •Pathologically and/or cytologically confirmed advanced malignancy that is refractory to standard therapy or for which there are no standard treatment options available
• •For oral or intravenous anticancer therapies, at least 4 weeks or 5 half-lives, whichever is shorter, need to have elapsed since the last dose
• •Recovery from adverse effects of prior therapy at time of enrollment to
• •o ≤ Grade 1 (excluding alopecia)
• •Agreement to forego any other chemotherapy, immunotherapy, radiotherapy, or investigational drug while enrolled on this trial except hormonal therapy for prostate cancer or radiotherapy for symptomatic bone metastases known to be present at Screening
• •Male or female subjects aged ≥ 18 years
• •ECOG performance status ≤ 2
• •Adequate organ function
• •Life expectancy of ≥ 3 months following trial entry
• •For women of childbearing potential, a negative serum pregnancy test result at Screening
• •For women of childbearing potential or men whose sexual partners are women of childbearing potential, agreement to use 2 methods of adequate contraception prior to trial entry, for the duration of the trial, and for 90 days after the last dose of trial medication
• •Signed and dated IRB-approved informed consent prior to any performance of protocol-specific screening procedures