Phase 1 Safety Study of Encorafenib in Chinese Patients With Advanced Metastatic BRAF V600E Mutant Solid Tumors
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a phase 1, multicenter, open-label, single-arm study to investigate the safety and
tolerability of encorafenib 300 mg once daily (QD) monotherapy in adult Chinese participants
with B-RAF Proto-oncogene, Serine/threonine Kinase V600E (BRAF V600E) mutant advanced solid
tumors (unresectable metastatic melanoma or metastatic non-small cell lung cancer (NSCLC)),
who are BRAF-inhibitor treatment-naïve and have failed the previous therapy(ies) in the
metastatic setting or are not eligible to standard therapy. Participants will be eligible for
the study based on identification of a BRAF V600E mutation in tumor tissue by a local
National Medical Products Administration (NMPA) approved assay obtained prior to screening.