Advanced Solid TumorPhase 1NCT05156203
Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
A Phase 1 study testing T-1301 Capsules in people with Advanced Solid Tumor and Lymphoma, run by Taivex Therapeutics Corporation at 3 sites in Taiwan.
Trial summary
T-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1, first-in-human (FIH) clinical trial in subjects with… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumor, Lymphoma
- What is being tested?
- T-1301 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesTaiwan
- Study dates
- 19 Dec 2021to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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.
- Subjects with histologically and cytologically confirmed advanced solid tumors (including lymphoma) that are refractory to standard treatments, or for whom no standard treatment is available, or who are not amenable or unwilling to receive standard treatments.
- Solid tumors that are measurable or evaluable 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Recovered from prior treatment-related toxicity to at least grade 1 with the exception of alopecia.
- Adequate organ function as defined by the following criteria:
- Serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)
- 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 the first dose of study drug.
- Subjects receiving any of the following anti-cancer therapy:
- Anti-cancer definitive radiation therapy (4,000-6,000 cGy) within 4 weeks prior to the first dose of study drug.
- Palliative radiation (≤ 10 fractions with total dose < 3,000 cGy) within 2 weeks prior to the first dose of study drug.
- Any systemic cytotoxic chemotherapy within 4 weeks prior to the first dose of study drug.
- Any targeted therapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first dose of study drug.
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- Any immunotherapy within 4 weeks prior to the first dose of study drug.
- Any interventional treatments in another clinical trial following Exclusion Criteria 2c, 2d and 2e.
- Subjects received blood transfusion or biological response modifiers (e.g., G-CSF) within 2 weeks prior to the first dose of study drug.
- Subject who received autologous bone marrow transplant or stem cells rescue within 6 months prior to the first dose of study drug.
- Subjects received strong inhibitors and/or inducers of CYP3A4 within 14 days prior to the first dose of study drug. A list of CYP3A4 modulators is provided in Appendix 3.
- Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
- Any of the following within 6 months of the first dose of study drug: 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 version 5.0 grade 2, or atrial fibrillation of any grade. Corrected QT interval by Fridericia (QTcF) ≥ 470 msec.
- Hypertension that cannot be controlled by medications (> 160/100 mm-Hg despite optimal medical therapy).
- AIDS-defining opportunistic infections within the past 12 months.
- Positive test for hepatitis B (HBsAg) or hepatitis C (anti-hepatitis C virus (anti-HCV) antibody), unless the HCV RNA level is below the limit of detection (for subjects with positive anti-HCV Ab).
- 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 breast feeding.
- 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Yi-Chang Liu, M.D., Ph.D., +886-7-312-1101 ext. 6113
Yi-Chang Liu, M.D., Ph.D.
- Recruiting
Taipei Veterans General Hospital
Taipei
Ming-Huang Chen, M.D., Ph.D., +886-2-2875-7270
Ming-Huang Chen, M.D., Ph.D.
- Recruiting
ChangGung Memorial Hospital, Linkou
Taoyuan City
Jen-Shi Chen, M.D., +886-3-328-1200 ext. 2517
Jen-Shi Chen, M.D.
About this study
Official title: A Phase I Study of Safety, Tolerability and Pharmacokinetics of T-1301 Capsules in Subjects With Advanced Solid Tumors
T-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1, first-in-human (FIH) clinical trial in subjects with advanced cancer.
This study is an open-label, multi-center, Phase I dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of T-1301 capsules in subjects with advanced solid tumors (including lymphoma), and to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Approximately 30 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until the MTD is reached.
Read more
T-1301 will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts. Subjects can continue with the treatment until one of the discontinuation criteria is met or until the planned stop of the study (12 months after the last subject receives the first dose of study drug), whichever comes first.
The planned dose levels are: 10, 20, 40, 60, 80, 100, 120, 140 and 160 mg/day. The dosing schedule will be once daily (QD) at the first dose level (10 mg/day) and be changed to twice daily (BID) starting with the second dose level. Other dose levels or dosing frequency may be explored based on safety and related drug exposure data following the decision of Safety Review Committee.
The dose escalation will follow accelerated titration and the Bayesian optimal interval (BOIN) design. During the initial accelerated titration phase, one (1) subject is enrolled per dose level. In the subsequent phase when the BOIN design is used, subjects will be enrolled in cohorts of size 3-6.
- Conditions
- Advanced Solid Tumor, Lymphoma
- Being tested
- T-1301 Capsules
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-1301 CapsulesDrug
T-1301 Capsules, 10 and 50 mg, are opaque hard gelatin capsules for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| T-1301 Capsules | Experimental | T-1301 Capsules will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts. Receives: Drug: T-1301 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The MTD will be selected based on isotonic regression as specified in Liu and Yuan (2015). Specifically, the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate is selected as the MTD. If there are ties, the higher dose level is selected when the isotonic estimate is lower than the target toxicity rate and the lower dose level is selected when the isotonic estimate is greater than or equal to the target toxicity rate. The target toxicity rate for the MTD is 30% 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).
Measured: First treatment cycle (i.e., the first 28 days post the first dose)
Recommended phase 2 dose (RP2D)
The recommended Phase 2 Dose (RP2D) will not exceed the MTD and will be determined by the Safety Review Committee.
Measured: First treatment cycle (i.e., the first 28 days post the first dose)
Frequency, types, severity and relationship to study drug of adverse events (AEs)
Safety and tolerability
Measured: At least 84 days (i.e., 56 days for two treatment cycles and 28 days for safety follow-up)
Secondary outcomes (6)
Pharmacokinetic parameters: Cmax
The maximum plasma concentration of T-1301 derived from the plasma concentration-time profiles
Measured: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters: Ctrough
The plasma concentration of T-1301 at trough level derived from the plasma concentration-time profiles
Measured: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters: Tmax
The time to reach maximum concentration of T-1301 derived from the plasma concentration-time profiles
Measured: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters: Area Under Curve (AUC)
The area under the concentration versus time curve of T-1301 derived from the plasma concentration-time profiles
Measured: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters:T1/2
The terminal half-life of T-1301 derived from the plasma concentration-time profiles.
Measured: Selected time points during the first 28-day treatment cycle
Objective response rate (ORR)
To assess preliminary anti-tumor activity with ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: At least 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start19 Dec 2021
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taivex Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156203
- Sponsor's protocol ID
- TAI-301
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 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-1301 Capsules in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05156203
- Acronym / sponsor ID
- TAI-301
- Conditions
- Advanced Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taivex Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Dec 2021 (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-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1, first-in-human (FIH) clinical trial in subjects with advanced cancer.
This study is an open-label, multi-center, Phase I dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of T-1301 capsules in subjects with advanced solid tumors (including lymphoma), and to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Approximately 30 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until the MTD is reached.
T-1301 will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts. Subjects can continue with the treatment until one of the discontinuation criteria is met or until the planned stop of the study (12 months after the last subject receives the first dose of study drug), whichever comes first.
The planned dose levels are: 10, 20, 40, 60, 80, 100, 120, 140 and 160 mg/day. The dosing schedule will be once daily (QD) at the first dose level (10 mg/day) and be changed to twice daily (BID) starting with the second dose level. Other dose levels or dosing frequency may be explored based on safety and related drug exposure data following the decision of Safety Review Committee.
The dose escalation will follow accelerated titration and the Bayesian optimal interval (BOIN) design. During the initial accelerated titration phase, one (1) subject is enrolled per dose level. In the subsequent phase when the BOIN design is used, subjects will be enrolled in cohorts of size 3-6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-1301 Capsules | Experimental | Drug: T-1301 CapsulesT-1301 Capsules will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts. |
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.
- Subjects with histologically and cytologically confirmed advanced solid tumors (including lymphoma) that are refractory to standard treatments, or for whom no standard treatment is available, or who are not amenable or unwilling to receive standard treatments.
- Solid tumors that are measurable or evaluable 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 (21 listed)
- Major surgery within 4 weeks prior to the first dose of study drug.
- Subjects receiving any of the following anti-cancer therapy:
- Any interventional treatments in another clinical trial following Exclusion Criteria 2c, 2d and 2e.
- Subjects received blood transfusion or biological response modifiers (e.g., G-CSF) within 2 weeks prior to the first dose of study drug.
- Subject who received autologous bone marrow transplant or stem cells rescue within 6 months prior to the first dose of study drug.
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-1301 CapsulesT-1301 Capsules, 10 and 50 mg, are opaque hard gelatin capsules for oral administration. | Drug | T-1301 Capsules |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: First treatment cycle (i.e., the first 28 days post the first dose)
The MTD will be selected based on isotonic regression as specified in Liu and Yuan (2015). Specifically, the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate is selected as the MTD. If there are ties, the higher dose level is selected when the isotonic estimate is lower than the target toxicity rate and the lower dose level is selected when the isotonic estimate is greater than or equal to the target toxicity rate. The target toxicity rate for the MTD is 30% 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).
Recommended phase 2 dose (RP2D)
Time frame: First treatment cycle (i.e., the first 28 days post the first dose)
The recommended Phase 2 Dose (RP2D) will not exceed the MTD and will be determined by the Safety Review Committee.
Frequency, types, severity and relationship to study drug of adverse events (AEs)
Time frame: At least 84 days (i.e., 56 days for two treatment cycles and 28 days for safety follow-up)
Safety and tolerability
6 secondary outcomes
Pharmacokinetic parameters: Cmax
Time frame: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters: Ctrough
Time frame: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters: Tmax
Time frame: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters: Area Under Curve (AUC)
Time frame: Selected time points during the first 28-day treatment cycle
Pharmacokinetic parameters:T1/2
Time frame: Selected time points during the first 28-day treatment cycle
Objective response rate (ORR)
Time frame: At least 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 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-1301 Capsules in people with Advanced Solid Tumor and Lymphoma, run by Taivex Therapeutics Corporation at 3 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 21 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact I-Fang Lee (+886-2-2748-6200 ext. 128, iflee@taivex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: First treatment cycle (i.e., the first 28 days post the first dose)). The study lists 3 primary outcomes in all. 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 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.