Clinical Trials List
Protocol NumberTAI-003
NCT Number(ClinicalTrials.gov Identfier)NCT04685473
Completed
2020-12-14 - 2025-04-30
Phase I
Recruiting2
A Phase I Study of Safety, Tolerability and Pharmacokinetics of T-1101 (Tosylate) Capsules in Subjects with Advanced Refractory Solid Tumors
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
Taivex Therapeutics Corporation
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 高育青 Division of Hematology & Oncology
- Yi-Chang Liu Division of Hematology & Oncology
- Tsung-Jang Yeh Division of Hematology & Oncology
- Hui-Ching Wang Division of Hematology & Oncology
- Shih-Feng Cho Division of Hematology & Oncology
- Hui-Hua Hsiao Division of Hematology & Oncology
- Jeng-Shiun Du Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Pin Su Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Chien-Chung Lin Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Po-Lan Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Refractory Solid Tumors
Objectives
T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) is a potent anti-cancer agent in numerous human cancer cell lines. In addition, oral administration of T-1101 (Tosylate) showed tumor growth inhibition in different mouse xenograft models of human cancers. In this study, safety, tolerability and pharmacokinetic (PK) of T-1101 (Tosylate) capsules will be evaluated and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.
Test Drug
T-1101 (Tosylate)
Active Ingredient
T-1101 (Tosylate)
Dosage Form
Capsules
Dosage
25, 100mg
Endpoints
Primary Outcome Measures :
Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy
Secondary Outcome Measures:
1.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)
2.Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate)
3.Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate)
4.Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate)
5.Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers
Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy
Secondary Outcome Measures:
1.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)
2.Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate)
3.Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate)
4.Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate)
5.Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers
Inclution Criteria
1.Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
2.Histologically and cytologically confirmed advanced malignancies that are refractory to standard treatments
3.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
4.Have a life expectancy of ≥3 months in the investigator's opinion
5.Females or males ≥ 20 years old
6.ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
7.Recovered from prior treatment-related toxicity to at least grade 1 with exception of alopecia
8.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)
9.Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
2.Histologically and cytologically confirmed advanced malignancies that are refractory to standard treatments
3.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
4.Have a life expectancy of ≥3 months in the investigator's opinion
5.Females or males ≥ 20 years old
6.ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
7.Recovered from prior treatment-related toxicity to at least grade 1 with exception of alopecia
8.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)
9.Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion Criteria
1.Major surgery within 4 weeks prior to starting T-1101 (Tosylate).
2.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)
3.Any interventional treatments in another clinical trial within 2 weeks or 5-half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
4.Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
5.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
6.Ongoing cardiac dysrhythmias of ≥ NCI CTCAE v5.0 grade 2, or atrial fibrillation of any grade
7.Hypertension that cannot be controlled by medications (> 160/100 mm-Hg despite optimal medical therapy).
8.Known human immunodeficiency virus (HIV) infection
9.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.
10.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.
11.If females, patient is pregnant or breastfeeding
12.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
2.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)
3.Any interventional treatments in another clinical trial within 2 weeks or 5-half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
4.Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
5.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
6.Ongoing cardiac dysrhythmias of ≥ NCI CTCAE v5.0 grade 2, or atrial fibrillation of any grade
7.Hypertension that cannot be controlled by medications (> 160/100 mm-Hg despite optimal medical therapy).
8.Known human immunodeficiency virus (HIV) infection
9.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.
10.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.
11.If females, patient is pregnant or breastfeeding
12.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
The Estimated Number of Participants
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Taiwan
30 participants
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Global
30 participants
