This is a first-in-human (FIH), multicenter, open-label Phase I dose escalation study to
evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent
reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.
The study will consist of two parts, dose escalation and dose expansion. A modified 3+3
design will be used to guide the dose escalation and the determination of the dose
recommended for dose expansion (DRDE). A sentinel cohort comprising of one subject will be
enrolled at a starting dose of 50 mg q.d. Subsequently, patients will be enrolled according
to the standard 3+3 dose escalation design to determine the DRDE. Once the DRDE has been
selected, TT-01488 of DRDE will be further tested in the dose expansion cohort to verify the
safety and preliminary efficacy as observed in the dose escalation cohorts. A recommended
Phase II dose (RP2D) may be determined based on the totality of safety, pharmacokinetics, and
efficacy data from the dose escalation cohorts and dose expansion cohort.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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