Advanced Solid TumorPhase 1NCT05649345
TR64 in Patients With Advanced Solid Tumors
A Phase 1 study testing TR64 in people with Advanced Solid Tumor, run by Tarapeutics Science Inc. at 2 sites in China.
Trial summary
This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- TR64
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesChina
- Study dates
- 12 Jan 2023to 30 Dec 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
- Males and/or females at least 18 years old when signing the informed consent form.
- Histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator.
- Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
- Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
- Life expectancy of at least 3 months.
- Acceptable organ function: Absolute neutrophil count(ANC)≥1.5×109/L; Platelet count(PLT)≥90×109/L; Hemoglobin(Hb)≥90 g/L; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN); Alanine aminotransferase(ALT)≤2.5×ULN; Aspartate aminotransferase(AST)≤2.5×ULN; Creatinine clearance ≥50ml/min.
- Fertile male and female must agree to use medically approved contraceptives during the study and within 90 days after the last dose of the study.
Who cannot join
- Known or suspected allergies to any of the investigational drug composition.
- Medical history and surgical history excluded according to the protocol.
- Any previous medical treatment history exclude from the protocol.
- Abnormal laboratory results exclude from the protocol.
- pregnant and lactating women (currently breast-feeding or less than six months after delivery although not breast-feeding).
- Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Huan Zhou, Ph.D, 13665527160, zhouhuanbest@vip.163.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
Funan Liu, MD Ph.D, 13609877906, lfn_clinical@126.com
About this study
Official title: A Single-arm, Open-Label, Dose Escalation , Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR64 in Patients With Advanced Solid Tumors
This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.
Read the detailed description
Patients will receive study treatment until criteria for study termination are met. A Safety Follow-up Visit will be conducted 28 days (±7 days) after the last dose of study treatment. Patients who discontinue study treatment for reasons other disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.
Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Tumor response will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using RECIST 1.1 criteria, assessed by the investigator.
- Conditions
- Advanced Solid Tumor
- Being tested
- TR64
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR64Drug
TR64 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
| Study group | Role | What they receive |
|---|---|---|
| TR64 | Experimental | Daily doses by oral administration on each day of each 28 day cycle. Starting dose is 25mg, with escalation to 400mg, and subsequent dose escalation using a modified Fibonacci algorithm. Receives: Drug: TR64 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events and Serious Adverse Events
Frequency, duration and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0
Measured: From the first dose to within 28 days after the last dose
Dose limited toxicities
Incidence of dose limited toxicities
Measured: within 28 days after the first dose
Maximum tolerated dose
Evaluated by safety review committee
Measured: Throughout the study for approximately 2 years
Recommended phaseII dose
Evaluated by safety review committee
Measured: Throughout the study for approximately 2 years
Secondary outcomes (7)
AUClast
Characterize the pharmacokinetic profile of TR64
Measured: within 35 days after the first dose
AUCinf
Characterize the pharmacokinetic profile of TR64
Measured: within 35 days after the first dose
Cmax
Characterize the pharmacokinetic profile of TR64
Measured: within 35 days after the first dose
Tmax
Characterize the pharmacokinetic profile of TR64
Measured: within 35 days after the first dose
CL/F
Characterize the pharmacokinetic profile of TR64
Measured: within 35 days after the first dose
Vz/F
Characterize the pharmacokinetic profile of TR64
Measured: within 35 days after the first dose
Terminal half-life (T1/2)
Characterize the pharmacokinetic profile of TR64
Measured: within 35 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start12 Jan 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarapeutics Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, PhD, Principal investigator, The First Affiliated Hospital of Bengbu Medical UniversityFunan Liu, MD, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649345
- Sponsor's protocol ID
- TR64-CN-PI-01
- Status last verified
- May 2024
- First submitted
- 22 Nov 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-Label, Dose Escalation , Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR64 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05649345
- Acronym / sponsor ID
- TR64-CN-PI-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Tarapeutics Science Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Dec 2022 (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.
This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.
Detailed description
Patients will receive study treatment until criteria for study termination are met. A Safety Follow-up Visit will be conducted 28 days (±7 days) after the last dose of study treatment. Patients who discontinue study treatment for reasons other disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.
Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Tumor response will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) scan using RECIST 1.1 criteria, assessed by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TR64 | Experimental | Drug: TR64Daily doses by oral administration on each day of each 28 day cycle. Starting dose is 25mg, with escalation to 400mg, and subsequent dose escalation using a modified Fibonacci algorithm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
- Males and/or females at least 18 years old when signing the informed consent form.
- Histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator.
- Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1.
- Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
Key exclusion criteria (6 listed)
- Known or suspected allergies to any of the investigational drug composition.
- Medical history and surgical history excluded according to the protocol.
- Any previous medical treatment history exclude from the protocol.
- Abnormal laboratory results exclude from the protocol.
- pregnant and lactating women (currently breast-feeding or less than six months after delivery although not breast-feeding).
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 |
|---|---|---|
| TR64TR64 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons. | Drug | TR64 |
Primary outcome
Adverse Events and Serious Adverse Events
Time frame: From the first dose to within 28 days after the last dose
Frequency, duration and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0
Dose limited toxicities
Time frame: within 28 days after the first dose
Incidence of dose limited toxicities
Maximum tolerated dose
Time frame: Throughout the study for approximately 2 years
Evaluated by safety review committee
Recommended phaseII dose
Time frame: Throughout the study for approximately 2 years
Evaluated by safety review committee
7 secondary outcomes
AUClast
Time frame: within 35 days after the first dose
AUCinf
Time frame: within 35 days after the first dose
Cmax
Time frame: within 35 days after the first dose
Tmax
Time frame: within 35 days after the first dose
CL/F
Time frame: within 35 days after the first dose
Vz/F
Time frame: within 35 days after the first dose
Terminal half-life (T1/2)
Time frame: within 35 days after the first dose
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 14 May 2024.
- 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.
Huan Zhou, PhD principal investigator
The First Affiliated Hospital of Bengbu Medical University
Funan Liu, MD, PhD principal investigator
First Hospital of China Medical University
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 TR64 in people with Advanced Solid Tumor, run by Tarapeutics Science Inc. at 2 sites in China.
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 8 inclusion and 6 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 14 May 2024. 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 China. 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 Yang Shu, MD. BS. (86-13918983465, shuyang@tarapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events and Serious Adverse Events (time frame: From the first dose to within 28 days after the last dose). The study lists 4 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 14 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.