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RecruitingNCT05751356Updated May 14, 2024

TR128 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of TR128 in Advanced Solid Tumor, sponsored by Tarapeutics Science Inc.. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Tarapeutics Science Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Advanced Solid Tumor

Browse trials for

03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Tarapeutics Science Inc. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    TR128

    Drug: TR128

Interventions

  • DrugTR128

    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.

06

What researchers measure

Primary outcomes

  1. Adverse Events and Serious Adverse Events

    Frequency, duration, and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0

    Time frame: from the first dose to within 30 days after the last dose

  2. Dose limited toxicities

    Incidence of dose limited toxicities

    Time frame: within 28 days after the first dose

  3. Maximum tolerated dose

    Evaluated by safety review committee

    Time frame: Throughout the study for approximately 2 years

  4. Recommended phase II dose

    Evaluated by safety review committee

    Time frame: Throughout the study for approximately 2 years

Secondary outcomes

  1. AUClast

    Characterize the pharmacokinetic profile of TR128

    Time frame: within 31 days after the first dose

  2. AUCinf

    Characterize the pharmacokinetic profile of TR128

    Time frame: within 31 days after the first dose

  3. Cmax

    Characterize the pharmacokinetic profile of TR128

    Time frame: within 31 days after the first dose

  4. Tmax

    Characterize the pharmacokinetic profile of TR128

    Time frame: within 31 days after the first dose

  5. CL/F

    Characterize the pharmacokinetic profile of TR128

    Time frame: within 31 days after the first dose

  6. Vz/F

    characterize the pharmacokinetic profile of TR128

    Time frame: within 31 days after the first dose

  7. Terminal half-life (T1/2)

    Characterize the pharmacokinetic profile of TR128

    Time frame: within 31 days after the first dose

  8. ORR

    Efficacy-overall response rate

    Time frame: throughout the study for approximately 2 years

  9. PFS

    Efficacy-progression free survival

    Time frame: throughout the study for approximately 2 years

  10. DOR

    Efficacy-duration of response

    Time frame: throughout the study for approximately 2 years

  11. DCR

    Efficacy-disease control rate

    Time frame: throughout the study for approximately 2 years

07

Study locations

3 of 3 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
    Recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, Heilonjiang 150081, China
    Recruiting
  • Tianjin Medical University Cancer Institute&Hospital
    Tianjin, Tianjin 300060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05751356
Lead sponsor
Tarapeutics Science Inc.
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Feb 23, 2024
Primary completion
Aug 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
May 14, 2024

Study contacts

Yang Shu, MD. BS.
Contact
shuyang@tarapeutics.com
+8613918983465
Lin Shen, MD, PhD
principal investigator · Peking University Cancer Hospital & Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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