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Brief Title: Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies
Official Title: A Phase I, First-In-Human, Multicenter, Open Label, and Dose-Escalation Study of TT-01488, Administered Orally in Adult Patients With B-Cell Malignancies
Study ID: NCT05275504
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Gabrail Cancer Center, Canton, Ohio, United States
The University of Texas MD Anderson Cancer Center (MDACC), Houston, Texas, United States
Name: Nitin Jain, MD
Affiliation: The University of Texas MD Anderson Cancer Center (MDACC)
Role: PRINCIPAL_INVESTIGATOR