Investigational Drug for Adults with Advanced Solid Tumors

Trial ID:
Michael P. Kosty, M.D.
The primary purpose of this clinical research study is to evaluate the safety and tolerability of investigational drug, BBP-398. BBP-398 is an oral medication that may stop certain proteins on tumor cells which may help to stop tumor cells from growing.

Eligible patients will be randomly assigned to take BBP-398 350mg or 450mg by mouth daily. You will know which BBP-398 dose level you have been assigned to.

Inclusion Criteria

Patients must:
  • Have a diagnosis of advanced solid tumor with documented MAPK-pathway alteration (KRAS, BRAF Class II/Class III, or NF1 LOF) or diagnosis of Chordoma Cancer.
  • Have measureable disease confirmed by Computerized Tomograpy scan (CT) or Magnetic Resonance Imaging (MRI).
  • Be capable of independently managing all self-care and be ambulatory and up and about at least 50% of each day (normal waking hours).
  • Be able to swallow oral medication (capsules) without chewing, crushing, or opening.
  • Be willing to record daily intake of study drug on a paper diary.

Exclusion Criteria

Patients must not:
  • Have history of significant cardiovascular disease.
  • Have received radiotherapy or proton therapy within 1 Week of the start of study treatment.
  • Have undergone major surgery within 4 Weeks of starting study treatment.
  • Have a diagnosis of another invasive malignancy within the previous 3 Yrs (curatively treated malignancies not expected to require additional treatment are excluded).
  • Have a gastrointestinal illness (ie_Crohn's Disease, Celiac Disease, or chronic gastritis) that may interfere with absorption of the oral study drug.
  • Be on dialysis.
  • Be pregnant or trying to get pregnant.

Additional Info

  • All study-related visits during the course of this clinical trial will occur at Scripps Clinic Torrey Pines (Geisel Pavilion).
  • Search NCT04528836 at website for more information.

Contact Info:

  • Clinical Research Services