Open Actively Recruiting

Study of the Safety and Pharmacokinetics of BGB-283 (Lifirfenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors

About

Brief Summary

This is a 2-part Phase 1b study of BGB-283 (lifirafenib) and PD-0325901 (mirdametinib) combination in participants with tumors.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
  • HIV
  • 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.

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Study Stats
Protocol No.
21-000980
Category
Hematology-Oncology
Oncology
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT03905148
For detailed technical eligibility, visit ClinicalTrials.gov.