Advanced Refractory Solid TumorsPhase 1NCT04685473
Safety and Tolerability Study for T-1101 (Tosylate) Capsules to Treat Advanced Refractory Solid Tumors
A Phase 1 study testing T-1101 (Tosylate) in people with Advanced Refractory Solid Tumors, run by Taivex Therapeutics Corporation at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Refractory Solid Tumors
- What is being tested?
- T-1101 (Tosylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesTaiwan
- Study dates
- 7 Jan 2021to 11 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
- Histologically and cytologically confirmed advanced malignancies that are refractory to standard treatments
- 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
- Have a life expectancy of ≥3 months in the investigator's opinion
- Females or males ≥ 20 years old
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
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- Recovered from prior treatment-related toxicity to at least grade 1 with exception of alopecia
- 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)
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Who cannot join
- Major surgery within 4 weeks prior to starting T-1101 (Tosylate).
- 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)
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- Any interventional treatments in another clinical trial within 2 weeks or 5-half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
- Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- 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
- Ongoing cardiac dysrhythmias of ≥ NCI CTCAE v5.0 grade 2, or atrial fibrillation of any grade
- Hypertension that cannot be controlled by medications (> 160/100 mm-Hg despite optimal medical therapy).
- Known human immunodeficiency virus (HIV) infection
- 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.
- 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.
- If females, patient is pregnant or breastfeeding
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
National Cheng Kung University Hospital
Tainan
About this study
Official title: A Phase I Study of Safety, Tolerability and Pharmacokinetics of T-1101 (Tosylate) Capsules in Subjects With Advanced Refractory Solid Tumors
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.
- Conditions
- Advanced Refractory Solid Tumors
- Being tested
- T-1101 (Tosylate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-1101 (Tosylate)Drug
T-1101 (Tosylate) Capsule
| Study group | Role | What they receive |
|---|---|---|
| T-1101 (Tosylate) | Experimental | Not described Receives: Drug: T-1101 (Tosylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy
MTD is highest dose level of 30% target toxicity rate and the MTD will be determined based on the occurrence of the dose-limiting toxicity (DLT) assessed using toxicity data during Cycle 1 (the first 28 days).
When following toxicity events occur within the first 28-day cycle, these toxicity will be defined as DLT.
- Hematological toxicities : prolonged grade 4 neutropenia for >7 days, grade 3 febrile neutropenia (an ANC < 1000/mm3 with a single temperature of > 38.3°C or a sustained temperature of > 38°C for more than 1 hour), grade 4 febrile neutropenia (febrile neutropenia with life-threatening consequences; urgent intervention indicated), Grade 3 or 4 neutropenia with IV treatment for infection and grade 3 thrombocytopenia with bleeding or grade 4 lasting 7 days.
- Non-hematological toxicities: grade 3 or 4 toxicities, Nausea and vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.
Measured: The first 28-day cycle
Secondary outcomes (5)
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)
Area under the plasma concentration versus time curve to the time of the last measurable concentration (AUC0-last) of T-1101 (Tosylate) will be estimated using non-compartmental analysis. If data permit, area under the plasma concentration versus time curve to infinity (AUC0-∞) will be also estimated.
Measured: Selected time points during first 28-day cycle
Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate)
Time to maximum plasma concentration (Tmax) of T-1101 (Tosylate) will be estimated using non-compartmental analysis. If data permit, terminal elimination half-life (T½ ) will be also estimated.
Measured: Selected time points during first 28-day cycle
Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate)
Oral plasma clearance (CL/F) of T-1101 (Tosylate) will be estimated using non-compartmental analysis.
Measured: Selected time points during first 28-day cycle
Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate)
Apparent volume of distribution (Vd/F) of T-1101 (Tosylate) will be estimated using non-compartmental analysis.
Measured: Selected time points during first 28-day cycle
Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers
Categorization of response based on RECIST 1.1.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start7 Jan 2021
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taivex Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685473
- Sponsor's protocol ID
- TAI-003
- Status last verified
- Jul 2026
- First submitted
- 13 Dec 2020
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Safety, Tolerability and Pharmacokinetics of T-1101 (Tosylate) Capsules in Subjects With Advanced Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT04685473
- Acronym / sponsor ID
- TAI-003
- Conditions
- Advanced Refractory Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Taivex Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-1101 (Tosylate) | Experimental | Drug: T-1101 (Tosylate) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
- Histologically and cytologically confirmed advanced malignancies that are refractory to standard treatments
- 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
- Have a life expectancy of ≥3 months in the investigator's opinion
- Females or males ≥ 20 years old
Key exclusion criteria (17 listed)
- Major surgery within 4 weeks prior to starting T-1101 (Tosylate).
- Subjects received any of the following anti-cancer therapies:
- Any interventional treatments in another clinical trial within 2 weeks or 5-half-lives (whichever is greater) prior to starting T-1101 (Tosylate)
- Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-1101 (Tosylate)T-1101 (Tosylate) Capsule | Drug | T-1101 (Tosylate) |
Primary outcome
Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy
Time frame: The first 28-day cycle
MTD is highest dose level of 30% target toxicity rate and the MTD will be determined based on the occurrence of the dose-limiting toxicity (DLT) assessed using toxicity data during Cycle 1 (the first 28 days). When following toxicity events occur within the first 28-day cycle, these toxicity will be defined as DLT. 1. Hematological toxicities : prolonged grade 4 neutropenia for >7 days, grade 3 febrile neutropenia (an ANC < 1000/mm3 with a single temperature of > 38.3°C or a sustained temperature of > 38°C for more than 1 hour), grade 4 febrile neutropenia (febrile neutropenia with life-threatening consequences; urgent intervention indicated), Grade 3 or 4 neutropenia with IV treatment for infection and grade 3 thrombocytopenia with bleeding or grade 4 lasting 7 days. 2. Non-hematological toxicities: grade 3 or 4 toxicities, Nausea and vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.
5 secondary outcomes
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)
Time frame: Selected time points during first 28-day cycle
Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate)
Time frame: Selected time points during first 28-day cycle
Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate)
Time frame: Selected time points during first 28-day cycle
Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate)
Time frame: Selected time points during first 28-day cycle
Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T-1101 (Tosylate) in people with Advanced Refractory Solid Tumors, run by Taivex Therapeutics Corporation at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy (time frame: The first 28-day cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.