This is a 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.
CLL/SLL treated with prior immunochemistry or BTK inhibitor containing regimen;
DLBCL treated with prior CD20 or anthracyclines containing regimen;
Other types of B-cell NHL treated with prior CD20 containing regimen
Absolute neutrophil count (ANC) ≥ 0.75×10^9/L, and ≥ 0.5×10^9/L if bone marrow involved
Women who are pregnant or lactating
Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years or which will not limit survival to < 2 years (Note: these cases must be discussed with the Medical Monitor and/or Investigator)
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or significant screening ECG abnormalities
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
Sequential
TT-01488 Tablets
DrugTT-01488 tablet will be administered orally once daily per protocol defined schedule.
Dose-Limiting Toxicity (DLT) of TT-01488
Safety and tolerability of TT-01488 as a single agent
Dose recommend for dose expansion (DRDE)
Safety and tolerability of TT-01488 as a single agent
Maximum Tolerated Dose (MTD), if reached, of TT-01488
Safety and tolerability of TT-01488 as a single agent
Number of participants with treatment-related adverse events (AEs)
Safety and tolerability of TT-01488 as a single agent. AEs will be assessed per CTCAE v5.0 or 2018 IWCLL and may include, but is not limited to, clinically abnormal laboratory tests, physical exams, vital signs, electrocardiograms, and ECOG performance status.
Area under the concentration time curve (AUC 0-t)
Pharmacokinetic (PK) profile of TT-01488 as a single agent
Maximum plasma concentration (Cmax)
Pharmacokinetic (PK) profile of TT-01488 as a single agent
Time to Maximum Plasma Concentration (Tmax)
Pharmacokinetic (PK) profile of TT-01488 as a single agent
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