Clinical Trials

Inclusion Criteria:

- Histologically or cytologically confirmed locally advanced or metastatic solid tumor
with a documented EGFR or HER2 exon 20 insertion mutation as determined by any nucleic
acid-based diagnostic testing method, or HER2 amplification/overexpression as
determined by an immunohistochemistry (IHC) or an in situ hybridization (ISH) test

- Previously received and progressed on or after available standard therapies and for
whom additional standard therapy is considered unsuitable or intolerable

-- NSCLC patients must have received platinum-based chemotherapy or other chemotherapy
regimen if platinum-based chemotherapy is contraindicated

- Agreement and ability to undergo pretreatment biopsy

- Measurable disease according to RECIST 1.1

- CNS involvement which is either previously treated and controlled, or asymptomatic

- ECOG performance status of 0 or 1

- Adequate organ function

Exclusion Criteria:

- Known EGFR T790M mutation

- Leptomeningeal disease and spinal cord compression

-- Except if LMD has been reported radiographically on baseline MRI, but is not
suspected clinically by the Investigator; the subject must be free of neurological
symptoms of LMD

- History of class III or IV congestive heart failure or severe non-ischemic
cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or
ventricular arrhythmia within the previous 6 months

- Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation
pneumonitis which required steroid treatment, or any evidence of clinically active ILD

- Known, symptomatic human immunodeficiency virus (HIV) infection

- Known active infection requiring treatment or history of hepatitis B virus (HBV) or
hepatitis C virus (HCV). Patients positive for HBsAg but normal HBV DNA level are
allowed.

- Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut
syndrome) or other malabsorption syndromes

- Any other concurrent serious uncontrolled medical, psychological, or addictive
conditions

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/1/23. Questions regarding updates should be directed to the study team contact.