This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or BBI503 in combination with Sorafenib. This study population is adult patients with advanced solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in combination therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
5 Sites
Chiba, Etc., Japan
Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs)
Time frame: 36 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 7 months
Pharmacokinetic profile of BBI503
Time frame: 37 days
Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks
The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: 6 months
Progression Free Survival
The time the participant stays on study until progression will be measured and recorded.
Time frame: Approximately 7 month
Overall Survival
Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.
Time frame: Approximately1 year
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