A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors (NCT06258408) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
China78 participantsStarted 2022-12-29
Plain-language 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.
Who can participate
Age range18 Years – 78 Years
SexALL
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Inclusion criteria
✓. 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 dose escalation trial, at least one evaluable lesion as defined by RECIST v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) score ≤1.
✓. Expected survival ≥ 3 months.
✓. Adequate organ function.
✓. Female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the ICF until 6 months after the last dose of study treatment.
✓. Fully informed of the study and voluntarily signed the informed consent form (ICF), and willing to follow and have the ability to complete all trial procedures.
Exclusion criteria
✕. Use of systemic immunosuppressive or systemic cortisol (≥10 mg prednisone or other equivalent hormones) within 4 weeks.
✕. Prior use of selective FGFR4 inhibitor and/or pan-FGFR inhibitor therapy.
✕. Use of cytotoxic chemotherapeutics within 4 weeks, OR use of state-approved Chinese traditional patent drugs/Chinese traditional drugs with an antitumor effect within 2 weeks.
✕. Anti-tumor endocrine therapy, radiotherapy, interventional embolization, radiofrequency, proton therapy, radioimmunotherapy, immunotherapy or other biotherapies within 4 weeks.
What they're measuring
1
Number of subjects with dose limiting toxicities (DLTs)
Timeframe: Single dose to the end of Cycle 1 (each cycle is 21 days)
2
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: From screening (Day -28 to Day -1) through up to 12 months or until disease progression