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TERMINATEDPHASE1

Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

A Phase I Safety and Tolerability Study of T-1101 (Tosylate) as a Oral Powder for Constitution (OPC) in Patients With Advanced Refractory Solid Tumors

NCT03195764•Taivex Therapeutics Corporation

View on ClinicalTrials.gov

Summary

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 PK of T-1101 (Tosylate) will be evaluated and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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.
+3 more criteria

Locations (4)

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Key Dates

Start Date

September 14, 2017

Primary Completion Date

October 1, 2019

Completion Date

October 23, 2019

Last Updated

November 18, 2022

Enrollment

ACTUAL participants

Conditions

Advanced Refractory Solid Tumors

Interventions

T-1101 (Tosylate)

DRUG

Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors

NCT05531708

Mesothelin-positive Advanced Refractory Solid Tumors

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COMPLETEDPHASE1

An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

NCT03349073

Advanced Refractory Solid Tumors

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UNKNOWNPHASE2

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

Inclusion Criteria

Exclusion Criteria

Exploratory Study of Novel MSLN CAR-T Cell Therapy in Patients With MSLN-positive Advanced Refractory Solid Tumors

An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors