Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Podpisana zgoda na udział w badaniu
- •Zaawansowany nowotwór (twardy lub chłoniak) oporny na standardowe leczenie lub brak dostępnego standardowego leczenia
- •Nowotwór mierzalny lub możliwy do oceny
- •Spodziewana długość życia co najmniej 3 miesiące
- •Wiek 20 lat lub więcej
- •Dobry stan ogólny (skala ECOG 0-1)
- •Wyzdrowienie z poprzednich skutków ubocznych leczenia
- •Prawidłowe wyniki badań krwi i funkcji nerek
✗ Disqualifies
- •Poważna operacja w ciągu 4 tygodni przed badaniem
- •Radioterapia w ciągu 2-4 tygodni przed badaniem
- •Chemioterapia w ciągu 4 tygodni przed badaniem
Simplified criteria — AI translation
Trial details
- Minimum age
- 20 Years
- Last updated (source)
- October 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (3)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
ChangGung Memorial Hospital, Linkou
Taoyuan City, Taiwan
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/6/2026.
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