Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ

A Multicenter, Phase 1/1b, Open Label Study Evaluating the Safety, Tolerability and Pharmacokinetics of Rilotumumab in Japanese Subjects

This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.

Key Inclusion Criteria:

• Japanese subjects with pathologically confirmed unresectable locally advanced or metastatic carcinoma which is refractory to standard therapies or for which there is no standard therapy (Part 1 only)
• Japanese subjects with pathologically confirmed MET-positive (fulfilling the MET IHC criteria as defined by validated IVD [in vitro diagnostic]) unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
• Eastern Cooperative Oncology Group (ECOG) Performance Status (0 or 1)
• Availability of archival tumor tissue (Part 2 only)
• Evaluable (measurable or non-measurable) disease by RECIST 1.1 criteria
• Able to tolerate infusions and take oral medications (Part 2 only)

Key Exclusion Criteria:

• Previous systemic therapy (including chemotherapy, biologic, immunotherapy, or investigational therapy) for locally advanced or metstatic gastric or GEJ adenocarcinoma (Part 2 only)
• Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemotherapy to enrollment (Part 2 only)
• Squamos cell history (Part 2 only)
• Known HER2-overexpressing unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma (Part 2 only)
• Resectable disease or suitable for definitive chemoradiation
• Subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding (Part 2 only)
• Known central nervous system metastases