Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
T-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral
drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate
the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1,
first-in-human (FIH) clinical trial in subjects with advanced cancer.
This study is an open-label, multi-center, Phase I dose-escalation study to evaluate the
safety, tolerability, and pharmacokinetics of T-1301 capsules in subjects with advanced solid
tumors (including lymphoma), and to identify the maximum tolerated dose (MTD) and the
recommended phase 2 dose (RP2D). Approximately 30 patients will be enrolled for the
dose-escalation phase. Actual number of patients will be determined by the number of dose
cohorts until the MTD is reached.
T-1301 will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed
by 7 days off treatment) in sequential cohorts. Subjects can continue with the treatment
until one of the discontinuation criteria is met or until the planned stop of the study (12
months after the last subject receives the first dose of study drug), whichever comes first.
The planned dose levels are: 10, 20, 40, 60, 80, 100, 120, 140 and 160 mg/day. The dosing
schedule will be once daily (QD) at the first dose level (10 mg/day) and be changed to twice
daily (BID) starting with the second dose level. Other dose levels or dosing frequency may be
explored based on safety and related drug exposure data following the decision of Safety
Review Committee.
The dose escalation will follow accelerated titration and the Bayesian optimal interval
(BOIN) design. During the initial accelerated titration phase, one (1) subject is enrolled
per dose level. In the subsequent phase when the BOIN design is used, subjects will be
enrolled in cohorts of size 3-6.