Completed

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

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What is being tested

T-1101 (Tosylate)

Drug
Who is being recruted

Over 20 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2017
See protocol details

Summary

Principal SponsorTaivex Therapeutics Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 14, 2017

Actual date on which the first participant was enrolled.

This study focuses on a new anti-cancer drug called T-1101 (Tosylate), developed by Taivex Therapeutics Corporation. The study aims to treat patients who have advanced solid tumors that have not responded to other treatments. The main goal is to evaluate the safety and tolerability of T-1101 (Tosylate) in these patients. This research is important as it could potentially provide a new treatment option for patients with advanced refractory solid tumors, addressing a significant unmet need in cancer care. During the study, participants receive T-1101 (Tosylate) orally for a maximum of two treatment cycles. If patients continue to benefit from the drug after these two cycles, they may be allowed to continue receiving T-1101 (Tosylate) at the discretion of the principal investigators and Taivex Therapeutics Corporation. The primary outcome measured in this study is the clinical tumor response to T-1101 (Tosylate), categorized based on a standard called RECIST 1.1.

Official TitleAn Extension Study of T-1101 (Tosylate) Administered Orally to Patients With Advanced Refractory Solid Tumors
NCT03349073
Principal SponsorTaivex Therapeutics Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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.
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.
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.
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.
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5 exclusion criteria prevent from participating
Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.
Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
Progressive or untreated metastatic brain or meningeal tumors.
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

China Medical University Hospital

Taichung, TaiwanOpen China Medical University Hospital in Google Maps
Suspended

National Cheng Kung University (NCKU) Hospital

Tainan, Taiwan
Suspended

Taipei Medical University Hospital

Taipei, Taiwan
Suspended

National Taiwan University Hospital

Taipei, Taiwan
Completed4 Study Centers