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COMPLETEDPHASE1

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

An Extension Study of T-1101 (Tosylate) Administered Orally to Patients With Advanced Refractory Solid Tumors

NCT03349073•Taivex Therapeutics Corporation

Summary

T-1101 is a novel anti-cancer agent being developed by Taivex Therapeutics Corporation, and is being studied in a phase I dose escalation trial, protocol TAI-001. That trial's primary aim is to study the safety and tolerability of T-1101 (Tosylate) in subjects with advanced refractory solid tumors, and provides for a maximum of 2 cycles of treatment. At the end of 2 cycles of treatment, it is likely that some patients will be continuing to receive clinical benefit from T-1101 (Tosylate). The intention of this program is to enable these patients to continue to receive T-1101 (Tosylate) at the discretion of the principal investigators and Taivex Therapeutics Corporation.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with advanced malignancy who are receiving T-1101 (Tosylate) in a previous Taivex Therapeutics Corp. sponsored study that has reached its endpoint, and who are, in the opinion of the investigator and/or sponsor, expected to continue to have an overall positive benefit/risk from continuing treatment.
•2. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing.
•3. Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of T-1101 (Tosylate) in this long term extension trial.
•4. Patients who have completed the End of Study assessments in their originating study. Every effort should be made to conduct the End of Study visit such that the patient does not have any interruption in T-1101 (Tosylate) dosing.
•5. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
•6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria

•1. Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.
•2. Hypertension that cannot be controlled by medications (\>150/100 mmHg despite optimal medical therapy).
•3. Progressive or untreated metastatic brain or meningeal tumors.
•4. Pregnancy or breastfeeding. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. 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.
•5. Substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.

Locations (4)

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University (NCKU) 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

June 24, 2019

Completion Date

June 24, 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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TERMINATEDPHASE1

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

NCT03195764

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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An Extension 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

Safety and Tolerability 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