Key Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic
solid tumor for which standard curative or palliative measures do not exist or are no
longer effective. In case of hepatocellular carcinoma, the diagnosis should be based
on at least 1 of the following:
1. The presence of at least 1 lesion, measuring ≥2 cm, with characteristic arterial
enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis
B or C infection.
2. The presence of liver lesion(s) (as defined in inclusion criteria 3a) with
alphafetoprotein ≥ 400 ng/mL.
3. Tissue confirmation.
2. For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing
should be documented.
3. Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
4. Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
5. The patient must have no clinically significant change in hepatic disease status
within the last 30 days before screening.
6. Patient with ascites must not have a paracentesis within 3 months of screening.
7. Protocol specified baseline hematology and kidney function laboratory values
Key Exclusion Criteria:
1. Concurrent participation in another therapeutic clinical study.
2. Symptomatic brain metastases or leptomeningeal involvement.
3. Major surgery within 4 weeks.
4. Clinically significant cardiovascular disease.
5. History of non-pharmacologically induced prolonged QT interval corrected for heart
rate interval.
6. Known active infections requiring ongoing treatment (bacterial, fungal, or viral,
including human immunodeficiency virus positivity).
7. Gastrointestinal disease or other malabsorption syndromes.
8. Current use or anticipated need for drugs that are known to be strong cytochrome P450
(CYP) 3A inhibitors or inducers.
Recruiting
