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Clinical Trials List

Protocol NumberTAI-001
NCT Number(ClinicalTrials.gov Identfier)NCT03195764

2017-06-28 - 2020-12-31

Phase I

Suspended4

ICD-10C80.1

Malignant (primary) neoplasm, unspecified

A Phase I safety and tolerability study of T-1101 (Tosylate) as a powder for constitution (OPC) in patients with advanced refractory solid tumors

  • Trial Applicant

    Efficient Pharma Management Corp.

  • Sponsor

    Taivex Therapeutics Corporation

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Li-Tzong Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Audit

None

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Principal Investigator Li-Yuan Bai 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Suspended

Audit

None

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Audit

None

Condition/Disease

Advanced Refractory Solid Tumors

Objectives

Primary Objectives:  To determine the safety and tolerability profile of T-1101 (Tosylate) including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD)  To determine the recommended Phase II dose and regimen(s) to initiate Phase II Secondary Objectives:  To define the pharmacokinetic (PK) profile of T-1101 (Tosylate)  To have preliminary assessment of anti-tumor activity of T-1101 (Tosylate)

Test Drug

T-1101 (Tosylate)

Active Ingredient

T-1101 (Tosylate)

Dosage Form

oral

Dosage

14.5, 25.0, 29.0 , 33.0

Endpoints

1. Primary endpoint:
 To determine the safety, tolerability and the DLT of T-1101
 To determine the MTD and potential phase II dose regimen(s) of T-1101 (Tosylate)
2. Secondary endpoints:
 To characterize the plasma pharmacokinetic profile of T-1101 and its metabolite(s)
following oral administration of T-1101 (Tosylate)
 To assess anti-tumor activity of T-1101 (Tosylate)
• Response rate using RECIST 1.1 for solid tumor
• Time to tumor progression

Inclution Criteria

Main inclusion criteria:
(1) Tumor eligibility:
 Histologically confirmed advanced malignancies refractory to standard active
treatment.
 Solid tumors that have measurable or evaluable disease as per Response Evaluation
Criteria in Solid Tumors (RECIST v. 1.1). Target lesions that have been previously
irradiated will not be considered measurable (lesion) unless increase in size is observed
following completion of radiation therapy.
(2) Able, in the investigator’s opinion, to have a life expectancy of more than 3 months.
(3) Female or male, 20 years of age or older.
(4) ECOG performance status 0 or 1.
(5) Resolution of all acute toxic effects of prior therapy or surgical procedures to no more than
grade 1 (except alopecia).
(6) Adequate organ function as defined by the following criteria:
 Serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or ALT ≤ 5 x
ULN if liver tumor is present.
 Total serum bilirubin ≤1.5 x ULN
 WBC ≧ 4000/µL with an absolute neutrophil count (ANC)  1500/µL
 Platelets ≧ 100,000/µL
 Hemoglobin ≧ 9.0 g/dL
 CCr ≧ 50 mL/min
(7) Signed and dated informed consent document indicating that the patient has been informed
of all the pertinent aspects of the trial prior to enrollment.
(8) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,
and other study procedures.

Exclusion Criteria

Main exclusion criteria:
(1) Major surgery (as defined by investigator) within 4 weeks of starting treatment.
(2) Extensive radiation therapy or systemic cytotoxic chemotherapy within 4 weeks before
starting study treatment or target therapy within 2 weeks of starting study treatment.
(3) Current treatment on clinical trial or within 4 weeks of completion of clinical trial for
another investigation drug.
(4) Documented or suspicious brain metastases, spinal cord compression, carcinomatous
meningitis, or leptomeningeal disease.
(5) Any of the following occurs within 6 months prior to 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 grade 2, or atrial fibrillation of any grade.
(7) Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
medical therapy).
(8) Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO
daily for deep vein thrombosis prophylaxis is allowed).
(9) Known human immunodeficiency virus infection.
(10)Pregnancy or breastfeeding. Female patients must be surgically sterile or be
postmenopausal, or must agree to the use of highly effective contraception during the
period of therapy. Highly effective method of birth control is defined as one that results in
a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly,
such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs),
sexual abstinence, or a vasectomized partner. All female patients with reproductive
potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male
patients must be surgically sterile or must agree to use effective contraception during the
period of therapy. The definition of effective contraception will be based on the judgment of
the principal investigator or a designated associate.
(11)Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
that would impart, in the judgment of the investigator and/or sponsor, excess risk associated
with study participation or study drug administration, which would make the patient
inappropriate for entry into this study.
(12)Patients with active infection should be excluded.
(13)Positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody).

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    40 participants

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