A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

Phase 1 Inclusion Criteria:

• Subjects with advanced and/or metastatic solid tumors who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist.
• ECOG performance status ≤ 2
• Accessible for treatment, PK sample collection and required study follow-up
• Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
• Exposure to any investigational agent within 4 weeks of study drug administration
• Subjects a history of gastrointestinal disease