The primary objectives of Part 1 of this study are to: * Assess the safety and tolerability of the combination of BGB-3245 and panitumumab in participants with advanced or metastatic colorectal cancer (CRC) with a known mutation status and tumor harboring an oncogenic mutation of v-Raf murine sarcoma viral oncogene homolog B; B-RAF proto-oncogene, serine/threonine kinase (BRAF), Kirsten rat sarcoma viral oncogene homolog (KRAS), or neuroblastoma RAS viral oncogene homolog (NRAS) with documented disease progression during or after at least 1 line of prior therapy. * Determine the maximum tolerated dose (MTD) of BGB-3245 in combination with panitumumab and the recommended phase 2 dose (RP2D) of the combination. The primary objective of Part 2 of this study is to determine the objective response rate (ORR) as assessed by initial investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with BGB-3245 and panitumumab combination treatment at the RP2D.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Oral capsule
Intravenous (IV) infusion via an infusion pump
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States
Duke Cancer Institute
Durham, North Carolina, United States
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, United States
Westmead Hospital
Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Part 1: Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately 2 years
Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 years
Part 1: Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately 2 years
Part 1: Number of Participants with Interruptions to Dosing with BGB-3245
Time frame: Up to approximately 2 years
Part 1: Number of Participants with Reductions in Dosing with BGB-3245
Time frame: Up to approximately 2 years
Part 1: MTD of BGB-3245
Time frame: Up to approximately 2 years
Part 1: RP2D of BGB-3245
Time frame: Up to approximately 2 years
Part 2: ORR as Assessed by Initial Investigator Review
Time frame: Up to approximately 2 years
Part 1 and 2: Plasma Concentrations of BGB-3245 and Any Relevant Metabolites
Time frame: Day 1 of each 28 day cycle (up to approximately 2 years)
Part 1: ORR as Assessed by Investigator Review using RECIST v1.1
Time frame: Up to approximately 2 years
Part 2: ORR as Assessed by Central Review
Time frame: Up to approximately 2 years
Part 1 and 2: Duration of Response (DoR)
Time frame: Up to approximately 2 years
Part 1 and 2: Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Part 1 and 2: Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Part 2: Number of Participants with SAEs
Time frame: Up to approximately 2 years
Part 2: Number of Participants with TEAEs
Time frame: Up to approximately 2 years
Part 2: Number of Participants with AESIs
Time frame: Up to approximately 2 years
Part 2: Number of Participants with Interruptions to Dosing with BGB-3245
Time frame: Up to approximately 2 years
Part 2: Number of Participants with Reductions in Dosing with BGB-3245
Time frame: Up to approximately 2 years
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