Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

A Non-Randomized, Open-Label, Multi-Center Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Japanese Subjects With Malignant Glioma

This study seeks to evaluate the tolerability, pharmacokinetics (PK), efficacy, and safety of ABT-414 in Japanese participants with newly diagnosed and recurrent, World Health Organization (WHO) grade III or IV malignant glioma.

Inclusion Criteria:

• Japanese participants with WHO grade III or IV malignant glioma
• 70 or above on Karnofsky Performance Status in Arm A of Phase 1 portion and Phase 2 portion
• 80 or above on Karnofsky Performance Status in Arm B and Arm C of Phase 1 portion
• Adequate bone marrow function
• Recurrent malignant glioma per RANO criteria in Arm A of Phase 1 portion and Phase 2 portion
• Histologically proven newly diagnosed malignant glioma in Arm B and Arm C of Phase 1 portion
• Participants must have confirmed EGFR amplification by central lab in Phase 2 portion

Exclusion Criteria:

• Anti-cancer treatment 28 days prior to study Day 1 for Arm A of Phase 1 portion and Phase 2 portion (except temozolomide therapy for newly diagnosed treatment for Phase 2 portion)
• Anti-cancer treatment prior to study Day 1 for Arm B and Arm C of Phase 1 portion
• Participant has received prior treatment with bevacizumabor, EGFR therapy in Arm A of Phase 1 portion and Phase 2 portion, or for recurrent glioblastoma in Phase 2 portion
• Participant has a history of major immunologic reaction to any Immunoglobulin G containing agents or component of ABT-414.