A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of BB102, a highly selective and potent FGFR4 inhibitor, as monotherapy in subjects with advanced solid tumors. This study has two phase: dose escalation phase and expansion phase.
Eligibility Criteria
Inclusion Criteria: 1. For the dose escalation trial, histologically, cytologically confirmed or clinically confirmed advanced solid tumors patients who without available standard treatment, have disease progression on standard treatment or cannot tolerate standard treatment. For the expansion trial, histologically or cytologically confirmed FGF19 or FGFR4 positive advanced primary HCC or other advanced solid tumors patients who without available standard treatment, have disease progression on standard treatment or cannot tolerate standard treatment. 2. For the dose escalation trial, at least one evaluable lesion as defined by RECIST v1.1. For the expansion trial, at least one measurable lesion as defined by RECIST v1.1. 3. Eastern Cooperative Oncology Group (ECOG) score ≤1. 4. Expected survival ≥ 3 months. 5. Adequate organ function. 6. Female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception