Melanoma Clinical Trial
Mirdametinib + BGB-3245 in Advanced Solid Tumors
A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.
Key Inclusion Criteria:
Able to provide informed consent
At least 18 years of age on day of signing ICF
Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated.
Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway
Part 2: oncogenic mutation or genomic aberration defined below:
Cohort A: cutaneous melanoma harboring NRAS mutations.
Cohort B: non-small cell lung cancer (NSCLC) harboring a KRAS mutation.
Cohort C: NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutations or BRAF Fusion mutation.
Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
Measurable disease per RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Adequate organ function and no transfusion within 14 days of first dose
Key Exclusion Criteria:
Central Nervous System metastases, leptomeningeal carcinomatosis or untreated spinal cord compression
History of glaucoma
Active parathyroid disorder or history of malignancy associated hypercalcemia
Clinically significant cardiac disease within the past 6 months of signing ICF
History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these agents
Severe or uncontrolled systemic disease
Inability to swallow oral medications
Clinically significant active infection (HIV, Hepatitis B or Hepatitis C)
History of or ongoing Immune Thrombocytopenia (ITP), Von Willebrand disease and/or other past or present bleeding disorders
Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
Systemic anti-cancer therapy within 2 weeks or 5 half-lives before first dose
Concomitant systemic or glucocorticoid therapy within 2 weeks before first dose
Concomitant medicines that are strong CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives before first dose
Live vaccine within 4 weeks before first dose
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There is 1 Location for this study
Boston Massachusetts, 02114, United States
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