Advanced Solid TumorPhase 1NCT05751356
TR128 in Patients With Advanced Solid Tumors
A Phase 1 study testing TR128 in people with Advanced Solid Tumor, run by Tarapeutics Science Inc. at 3 sites in China.
Trial summary
This is a open-label, 3+3 design, dose escalation and expansion, phase I study, to evaluate the safety and tolerability, and to determine the Recommended Phase II Dose (RP2D) of TR128 when administered qd in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- TR128
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesChina
- Study dates
- 23 Feb 2024to 30 Dec 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 18 years and older
- 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) ≤1 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; International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5×Upper limit of normal value (ULN), Activated Partial Thromboplastin Time (APTT)≤1.5×ULN ; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN) (≤3× ULN if there is liver involvement); Alanine aminotransferase(ALT)≤2.5×ULN and aspartate aminotransferase(AST)≤2.5×ULN (≤ 5 × ULN if there is liver involvement); Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance (CCr) ≥50 ml/min (calculated by Cockcroft-Gault formula).
- fertile male and female must agree to use medically approved contraceptives during the study and within 6 months after the last dose of the study.
Who cannot join
- 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).
- unsuitable for the study by the investigator's judgment.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
LIN SHEN, M.D., +86 13911219511, linshenpku@163.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilonjiang, 150081
YANQIAO ZHANG, M.D., +86 451-85718890, yanqiaozhang@126.com
- Recruiting
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300060
TING DENG, M.D., +86 18920193527, xymcdengting@126.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR128 in Patients With Advanced Solid Tumors
This is a open-label, 3+3 design, dose escalation and expansion, phase I study, to evaluate the safety and tolerability, and to determine the Recommended Phase II Dose (RP2D) of TR128 when administered qd in patients with advanced solid tumors. Up to 5 cohorts of 3-6 patients each will be treated in dose escalation phase of the study. One cycle is 28 days. Dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of TR128 at the RP2D.
Read the detailed description
This phase I study of TR128 will investigate the tolerability, safety, pharmacokinetics (PK) and preliminary efficacy of TR128, and will define the maximum tolerated dose (MTD) of TR128 using 3+3 design. A dose expansion phase will identify the recommended phase 2 dose. In this clinical study, TR128 is given orally daily. A treatment cycle is defined as 28 days. Patients will receive study treatment until criteria for study termination are met. A safety follow-up visit will be conducted 28 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 (AEs) 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 RECIST1.1 criteria, assessed by the investigator.
- Conditions
- Advanced Solid Tumor
- Being tested
- TR128
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR128Drug
TR128 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. Starting dose is 100mg, with escalation to 500mg.
| Study group | Role | What they receive |
|---|---|---|
| TR128 | Experimental | Not described Receives: Drug: TR128 |
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 30 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 phase II dose
Evaluated by safety review committee
Measured: Throughout the study for approximately 2 years
Secondary outcomes (11)
AUClast
Characterize the pharmacokinetic profile of TR128
Measured: within 31 days after the first dose
AUCinf
Characterize the pharmacokinetic profile of TR128
Measured: within 31 days after the first dose
Cmax
Characterize the pharmacokinetic profile of TR128
Measured: within 31 days after the first dose
Tmax
Characterize the pharmacokinetic profile of TR128
Measured: within 31 days after the first dose
CL/F
Characterize the pharmacokinetic profile of TR128
Measured: within 31 days after the first dose
Vz/F
characterize the pharmacokinetic profile of TR128
Measured: within 31 days after the first dose
Terminal half-life (T1/2)
Characterize the pharmacokinetic profile of TR128
Measured: within 31 days after the first dose
ORR
Efficacy-overall response rate
Measured: throughout the study for approximately 2 years
PFS
Efficacy-progression free survival
Measured: throughout the study for approximately 2 years
DOR
Efficacy-duration of response
Measured: throughout the study for approximately 2 years
DCR
Efficacy-disease control rate
Measured: throughout the study for approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start23 Feb 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (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
- Model description
- Dose escalation and expansion
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarapeutics Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751356
- Sponsor's protocol ID
- TR128-CN-PI-01
- Status last verified
- May 2024
- First submitted
- 20 Feb 2023
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR128 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05751356
- Acronym / sponsor ID
- TR128-CN-PI-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tarapeutics Science Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Mar 2023 (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, 3+3 design, dose escalation and expansion, phase I study, to evaluate the safety and tolerability, and to determine the Recommended Phase II Dose (RP2D) of TR128 when administered qd in patients with advanced solid tumors. Up to 5 cohorts of 3-6 patients each will be treated in dose escalation phase of the study. One cycle is 28 days. Dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of TR128 at the RP2D.
Detailed description
This phase I study of TR128 will investigate the tolerability, safety, pharmacokinetics (PK) and preliminary efficacy of TR128, and will define the maximum tolerated dose (MTD) of TR128 using 3+3 design. A dose expansion phase will identify the recommended phase 2 dose. In this clinical study, TR128 is given orally daily. A treatment cycle is defined as 28 days. Patients will receive study treatment until criteria for study termination are met. A safety follow-up visit will be conducted 28 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 (AEs) 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 RECIST1.1 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
- Model description
- Dose escalation and expansion
| Arm | Type | Receives |
|---|---|---|
| TR128 | Experimental | Drug: TR128 |
Who may qualify
- Ages
- 18 years and older
- 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) ≤1 at screening.
Key exclusion criteria (5 listed)
- 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).
- unsuitable for the study by the investigator's judgment.
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 |
|---|---|---|
| TR128TR128 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. Starting dose is 100mg, with escalation to 500mg. | Drug | TR128 |
Primary outcome
Adverse Events and Serious Adverse Events
Time frame: from the first dose to within 30 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 phase II dose
Time frame: Throughout the study for approximately 2 years
Evaluated by safety review committee
11 secondary outcomes
AUClast
Time frame: within 31 days after the first dose
AUCinf
Time frame: within 31 days after the first dose
Cmax
Time frame: within 31 days after the first dose
Tmax
Time frame: within 31 days after the first dose
CL/F
Time frame: within 31 days after the first dose
Vz/F
Time frame: within 31 days after the first dose
Terminal half-life (T1/2)
Time frame: within 31 days after the first dose
ORR
Time frame: throughout the study for approximately 2 years
PFS
Time frame: throughout the study for approximately 2 years
DOR
Time frame: throughout the study for approximately 2 years
DCR
Time frame: throughout the study for approximately 2 years
Results and safety
Results are not available in the source record.
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. This study is not recruiting at the moment.
Lin Shen, MD, PhD principal investigator
Peking University Cancer Hospital & Institute
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 TR128 in people with Advanced Solid Tumor, run by Tarapeutics Science Inc. at 3 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 5 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: status not confirmed, 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 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Shu, MD. BS. (+8613918983465, 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 30 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.