- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04685473
Safety and Tolerability Study for T-1101 (Tosylate) Capsules to Treat Advanced Refractory Solid Tumors
A Phase I Study of Safety, Tolerability and Pharmacokinetics of T-1101 (Tosylate) Capsules in Subjects With Advanced Refractory Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Chieh Hua LEE, PhD
- Phone Number: 123 +886227486200
- Email: chlee@taivex.com
Study Contact Backup
- Name: TJ Wu
- Phone Number: 163 +886227486200
- Email: tj_wu@taivex.com
Study Locations
-
-
-
Kaohsiung, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Tainan, Taiwan
- National Cheng Kung University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
- Histologically and cytologically confirmed advanced malignancies that are refractory to standard treatments
- Solid tumors that are measurable or evaluable as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy
- Have a life expectancy of ≥3 months in the investigator's opinion
- Females or males ≥ 20 years old
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
- Recovered from prior treatment-related toxicity to at least grade 1 with exception of alopecia
Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin ≤ 1.5 x ULN
- Absolute neutrophil count (ANC) ≥ 1500/μL
- Platelets ≥ 100,000/μL
- Hemoglobin ≤ 9.0 g/dL
- Creatinine clearance (CrCl) ≥ 50 mL/min CrCl = [(140 - age (year)) x weight (kg)] / (serum creatinine x 72) (x 0.85 for females)
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion Criteria:
- Major surgery within 4 weeks prior to starting T-1101 (Tosylate).
Subjects received any of the following anti-cancer therapies:
- Anti-cancer radiation therapy within 2 weeks prior to starting T-1101 (Tosylate).
- Palliative radiation (≤ 10 fractions) within 48 hours prior to the screening
- Any systemic cytotoxic chemotherapy within 2 weeks or 5 half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
- Any target therapy within 2 weeks prior to starting T-1101 (Tosylate)
- Any interventional treatments in another clinical trial within 2 weeks or 5-half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
- Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- Any of the following within 6 months of starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack
- Ongoing cardiac dysrhythmias of ≥ NCI CTCAE v5.0 grade 2, or atrial fibrillation of any grade
- Hypertension that cannot be controlled by medications (> 160/100 mm-Hg despite optimal medical therapy).
- Known human immunodeficiency virus (HIV) infection
- A positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV (hepatitis C virus) antibody), unless the HBV (hepatitis B virus) DNA level and/or HCV RNA level is below the limit of detection.
Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.
Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
- If females, patient is pregnant or breastfeeding
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and/or sponsor, excess risk associated with study participation or study drug administration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T-1101 (Tosylate)
|
T-1101 (Tosylate) Capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy
Time Frame: The first 28-day cycle
|
MTD is highest dose level of 30% target toxicity rate and the MTD will be determined based on the occurrence of the dose-limiting toxicity (DLT) assessed using toxicity data during Cycle 1 (the first 28 days). When following toxicity events occur within the first 28-day cycle, these toxicity will be defined as DLT.
|
The first 28-day cycle
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) to the time of the last measurable concentration and to infinity of T-1101 (Tosylate)
Time Frame: Selected time points during first 28-day cycle
|
Area under the plasma concentration versus time curve to the time of the last measurable concentration (AUC0-last) of T-1101 (Tosylate) will be estimated using non-compartmental analysis.
If data permit, area under the plasma concentration versus time curve to infinity (AUC0-∞) will be also estimated.
|
Selected time points during first 28-day cycle
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Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate)
Time Frame: Selected time points during first 28-day cycle
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Time to maximum plasma concentration (Tmax) of T-1101 (Tosylate) will be estimated using non-compartmental analysis.
If data permit, terminal elimination half-life (T½ ) will be also estimated.
|
Selected time points during first 28-day cycle
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Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate)
Time Frame: Selected time points during first 28-day cycle
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Oral plasma clearance (CL/F) of T-1101 (Tosylate) will be estimated using non-compartmental analysis.
|
Selected time points during first 28-day cycle
|
Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate)
Time Frame: Selected time points during first 28-day cycle
|
Apparent volume of distribution (Vd/F) of T-1101 (Tosylate) will be estimated using non-compartmental analysis.
|
Selected time points during first 28-day cycle
|
Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers
Time Frame: Up to 2 years
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Categorization of response based on RECIST 1.1.
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Up to 2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAI-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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