Status and phase
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About
This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Able to provide informed consent
Age 18 on day of signing informed consent form (ICF) or of the legal age of consent in the jurisdiction in which the study is taking place
Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or central nervous system) who have experienced disease progression
Must have archival tumor tissue or agree to tumor biopsy
Measurable disease per RECIST 1.1
Eastern Cooperative Oncology Group performance status of less than or equal to 1
Life expectancy is greater than 12 weeks of the signing of ICF.
Adequate organ function and no transfusion within 14 days of first dose.
Females are of non-child bearing potential or willing to use contraception.
Males vasectomized or agree to use contraception.
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
105 participants in 2 patient groups
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Central trial contact
BeiGene
Data sourced from clinicaltrials.gov
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