A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
Stopped early · Phase 1
Conditions studied: Colorectal Cancer, Pancreatic Ductal Cancer, Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
In brief
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.
Key facts
- Study ID
- NCT06194877
- Run by
- MapKure, LLC
- People needed
- 13
- Starts
- 2024-04-18
- Expected to finish
- 2025-03-10
- Last updated by the study team
- 2025-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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