Actively Recruiting
Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
Led by Taivex Therapeutics Corporation · Updated on 2024-11-12
30
Participants Needed
3
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after being informed about the study
- Histologically or cytologically confirmed advanced solid tumors (including lymphoma) not responding to standard treatments or without available standard treatments
- Measurable or evaluable solid tumors according to RECIST v1.1 criteria
- Life expectancy of at least 3 months as judged by the investigator
- Male or female aged 20 years or older
- ECOG performance status of 0 or 1
- Recovery from prior treatment side effects to grade 1 or better, except for alopecia
- Adequate organ function with ALT ≤ 3 times upper normal limit, bilirubin ≤ 1.5 times upper normal limit, neutrophils ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL, and creatinine clearance ≥ 50 mL/min
- Willingness and ability to comply with study visits, treatments, and tests
You will not qualify if you...
- Major surgery within 4 weeks before first dose
- Receiving certain anti-cancer treatments within specified times before first dose: definitive radiation therapy within 4 weeks, palliative radiation within 2 weeks, systemic chemotherapy within 4 weeks, targeted therapy within 2 weeks or 5 half-lives, immunotherapy within 4 weeks
- Participation in other clinical trials with interventional treatments overlapping with exclusion periods
- Blood transfusion or biological response modifiers within 2 weeks before first dose
- Autologous bone marrow transplant or stem cell rescue within 6 months before first dose
- Use of strong CYP3A4 inhibitors or inducers within 14 days before first dose
- Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- Major heart conditions within 6 months before first dose, including heart attack, unstable angina, bypass surgery, heart failure, or stroke
- Ongoing significant heart rhythm problems or atrial fibrillation
- QT interval corrected by Fridericia ≥ 470 msec
- Uncontrolled high blood pressure (>160/100 mmHg) despite treatment
- AIDS-defining infections within past 12 months
- Positive hepatitis B or C infection unless virus not detectable
- Men and women of childbearing potential unwilling to use effective contraception during study
- Pregnant or breastfeeding women
- Other severe medical or psychiatric conditions that increase study risk as judged by investigator or sponsor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
2
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
3
ChangGung Memorial Hospital, Linkou
Taoyuan City, Taiwan
Actively Recruiting
Research Team
I
I-Fang Lee
CONTACT
T
TJ Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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