Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Official Title

A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors

Keywords

Solid Tumor, Adult, Neoplasms, Lifirafenib, mirdametinib

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Able to provide informed consent
  2. 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
  3. Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or central nervous system) who have experienced disease progression
  4. Part A: NSCLC, CRC, ovarian cancer, endometrial cancer, thyroid cancer, melanoma, pancreatic cancer, and other)
  5. 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
  6. Must have archival tumor tissue or agree to tumor biopsy
  7. Measurable disease per RECIST 1.1
  8. Eastern Cooperative Oncology Group performance status of less than or equal to 1
  9. Life expectancy is greater than 12 weeks at the of signing ICF.
  10. Adequate organ function and no transfusion within 14 days of first dose.
  11. Females are of non-child bearing potential or willing to use contraception.
  12. . Males vasectomized or agree to use contraception.

You CAN'T join if...

  1. Central Nervous System metastasis
  2. Any retinal pathology considered to be a risk factor for central serous retinopathy
  3. History of glaucoma
  4. Active parathyroid disorder or history of malignancy associated hypercalcemia
  5. Clinically significant cardiac disease within the past 6 months of signing ICF.
  6. LVEF less than 50%
  7. Abnormal QT interval at Screening
  8. Severe uncontrolled systemic disease
  9. HIV
  10. . Clinically significant active or known history of liver disease. (Hepatitis B and Hepatitis C)
  11. . Hemorrhage or bleeding event at NCI-CTCAE v5.0 Grade 3 or higher within 28 days of first dose.
  12. . history of or ongoing Von Willebrand disease and/or other past or present bleeding disorders
  13. . Increased serum calcium
  14. . Inability to swallow oral medications
  15. . 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
  16. . Concomitant systemic or glucocorticoid therapy within 2 weeks
  17. . Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
  18. . Concomitant medicines that are strong CYP3A inhibitors
  19. . History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these drugs
  20. . Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
  21. . 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.

Locations

  • University of California Los Angeles accepting new patients
    Santa Monica California 90404 United States
  • MD Anderson accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT03905148
Phase
Phase 1/2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 105 study participants
Last Updated