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 range
18 Years – 78 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Use of other clinical investigational drug or therapy that was not marketed within 4 weeks.
. The patient is receiving drugs or therapies prohibited in the protocol and cannot discontinue such use at least 2 weeks.
. Pregnant or lactating females.
. Presence of clinically significant gastrointestinal disorder that may affect the intake, transport, or absorption of the study drug at screening.