- Trial ID:
- Michael P. Kosty, M.D.
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 CriteriaPatients 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 CriteriaPatients 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.
- All study-related visits during the course of this clinical trial will occur at Scripps Clinic Torrey Pines (Geisel Pavilion).
- Search NCT04528836 at https://clinicaltrials.gov website for more information.
- Clinical Research Services