for people ages 18 years and up (full criteria)
study started
completion around
Principal Investigator
by Gregory Daniels, MD (ucsd)
Headshot of Gregory Daniels
Gregory Daniels



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.

Official Title

A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors


Advanced Solid Tumor, Neoplasms, Mirdametinib, BGB-3245


You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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


  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center accepting new patients
    Dallas Texas 75246 United States

Lead Scientist at University of California Health

  • Gregory Daniels, MD (ucsd)
    Dr. Daniels coordinates our clinical program in melanoma. His own research involves understanding the link between autoimmunity and tumor immunity in developing more effective and less toxic vaccines and immune stimulatory approaches for patients with melanoma.


accepting new patients
Start Date
Completion Date
SpringWorks Therapeutics, Inc.
Phase 1/2 research study
Study Type
Expecting 136 study participants
Last Updated