Evaluating TR128 for patients with advanced solid tumors
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR128 in Patients With Advanced Solid Tumors
This study is testing a new medication called TR128 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tarapeutics Science Inc. Industry-sponsored |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT05751356 on ClinicalTrials.gov |
What this trial studies
This phase I clinical trial investigates the safety, tolerability, and preliminary efficacy of TR128 in patients with advanced solid tumors. The study employs a 3+3 dose escalation design to determine the maximum tolerated dose and the recommended phase II dose. Patients will receive TR128 orally on a daily basis for 28-day treatment cycles, with follow-up assessments to monitor adverse events and tumor response using imaging techniques. The trial aims to provide insights into the pharmacokinetics and potential anti-tumor activity of TR128.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced solid tumors who have failed or are not suitable for standard treatments.
Not a fit: Patients with early-stage tumors or those who are eligible for standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in evaluating new treatments for advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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.
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Harbin Medical University Cancer Hospital — Harbin, Heilonjiang, China (Recruiting)
- Tianjin Medical University Cancer Institute&Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Lin Shen, MD, PhD — Peking University Cancer Hospital & Institute
- Study coordinator: Yang Shu, MD. BS.
- Email: shuyang@tarapeutics.com
- Phone: +8613918983465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.