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A Phase Ib/II Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

Primary Objectives The primary objective of Phase Ib of this study is: To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of BBI608 when administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, regorafenib or irinotecan in adult patients with advanced gastrointestinal cancer. The primary objective of Phase II of this study is: To assess the objective response rate (ORR) of BBI608 administered in combination with FOLFIRI (with bevacizumab if clinically indicated) in patients with FOLFIRI/XELIRIrefractory mCRC. Secondary Objectives The secondary objectives of this study are: To determine the pharmacokinetic profile of BBI608 administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib. To determine the pharmacodynamics (i.e., identify biomarkers) of BBI608 administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, regorafenib or irinotecan. To assess the preliminary anti-tumor activity of BBI608 administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, regorafenib or irinotecan. To assess the disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) of BBI608 administered in combination with FOLFIRI (with bevacizumab if clinically indicated) in patients with FOLFIRI/XELIRI-refractory mCRC.

Primary Objectives The primary objective of Phase Ib of this study is: To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of BBI608 when administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, regorafenib or irinotecan in adult patients with advanced gastrointestinal cancer. The primary objective of Phase II of this study is: To assess the objective response rate (ORR) of BBI608 administered in combination with FOLFIRI (with bevacizumab if clinically indicated) in patients with FOLFIRI/XELIRIrefractory mCRC. Secondary Objectives The secondary objectives of this study are: To determine the pharmacokinetic profile of BBI608 administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib. To determine the pharmacodynamics (i.e., identify biomarkers) of BBI608 administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, regorafenib or irinotecan. To assess the preliminary anti-tumor activity of BBI608 administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, regorafenib or irinotecan. To assess the disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) of BBI608 administered in combination with FOLFIRI (with bevacizumab if clinically indicated) in patients with FOLFIRI/XELIRI-refractory mCRC.