Open Actively Recruiting
Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors
This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.
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
- Part A: NSCLC, CRC, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, and other)
- Part B: Group 1: NSCLC, Group 2: endometrial cancer, Group 3: Tumor types of interest based on preliminary anti-tumor activities observed in Part A
- 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 at the of signing 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:
- Central Nervous System metastasis
- Any retinal pathology considered to be a risk factor for central serous retinopathy
- History of glaucoma
- Active parathyroid disorder or history of malignancy associated hypercalcemia
- Clinically significant cardiac disease within the past 6 months of signing ICF.
- LVEF less than 50%
- Abnormal QT interval at Screening
- Severe uncontrolled systemic disease
- Clinically significant active or known history of liver disease. (Hepatitis B and Hepatitis C)
- Hemorrhage or bleeding event at NCI-CTCAE v5.0 Grade 3 or higher within 28 days of first dose.
- history of or ongoing Von Willebrand disease and/or other past or present bleeding disorders
- Increased serum calcium
- Inability to swallow oral medications
- Ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks. No chemotherapy, immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
- Concomitant systemic or glucocorticoid therapy within 2 weeks
- Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
- Concomitant medicines that are strong CYP3A inhibitors
- History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these drugs
- Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
- Has been administered a live vaccine within 4 weeks (28 days) of initiation of study treatment. NOTE: injectable seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Join this Trial
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- UCLA Santa Monica