A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Sol… (NCT04209465) | Clinical Trial Compass
TerminatedPhase 1
A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
Stopped: The development of BDTX-189 was discontinued by the sponsor.
United States91 participantsStarted 2019-12-19
Plain-language summary
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal growth factor receptor (EGFR/ErbB1). The main goals of this study were to:
* Find the recommended dose of BDTX-189 that can be given safely to participants
* Learn more about the side effects of BDTX-189
* Learn what the body does to BDTX-189 after it has been taken (pharmacokinetics or PK)
* Determine the preliminary antitumor activity of BDTX-189 in participants with select allosteric ErbB gene mutations
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Allosteric HER2 or HER3 mutation(s)
✓. EGFR or HER2 exon 20 insertion mutation(s)
✓. HER2 amplified or overexpressing tumors
✓. EGFR exon 19 deletion or L858R mutation
Exclusion criteria
✕. Serum creatinine ≥1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≤60 mL/min using Cockcroft-Gault equation
✕. Total bilirubin ≥1.5 × ULN or ≥3.0 × ULN in the presence of documented Gilbert's syndrome
✕. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 × ULN, or AST or ALT ≥5.0 × ULN in the presence of liver metastases
✕. Cardiac failure New York Heart Association Class III or IV, or left ventricular ejection fraction (LVEF) \<50% or below the lower limit of the Institution's normal range