Using TR115 to treat patients with relapsed or refractory non-Hodgkin's lymphoma or advanced solid tumors
A Phase I Clinical Study to Characterize Safety, Tolerability, and Pharmacokinetics of TR115 in Patients With Relapsed / Refractory Non-Hodgkin's Lymphoma or Advanced Solid Tumors
This study is testing a new treatment called TR115 to see if it is safe and effective for adults with relapsed non-Hodgkin's lymphoma or advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tarapeutics Science Inc. Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05650580 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial evaluates the safety and tolerability of TR115 in adult patients with relapsed or refractory non-Hodgkin's lymphoma or advanced solid tumors. The study employs an open-label, dose escalation design, where patients will receive the treatment in cohorts to determine the recommended phase II dose. Participants will be monitored for adverse events and tumor response through imaging assessments. The trial aims to gather data on the pharmacokinetics and efficacy of TR115 after the initial dose escalation phase.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory non-Hodgkin's lymphoma or advanced solid tumors who have failed prior treatments.
Not a fit: Patients with early-stage cancers or those who have not received any prior systemic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat cancers.
How similar studies have performed: Other studies have shown promise with similar dose escalation approaches in oncology, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Key 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. * tumor type criteria: 1. relapsed/refractory histologically or cytologically documented non-hodgkin's lymphoma must have received at least 1 prior systemic therapies, including but not limited as below: Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), Peripheral T-cell lymphoma-Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell Lymphoma (AITL), Anaplastic Large Cell Lymphoma (ALCL). 2. 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. * eastern cooperative oncology group performance status (ECOG) ≤2 at screening. * life expectancy of at least 3 months. * acceptable organ function: absolute neutrophil count (ANC)≥1.0×109/L (note: growth factor supports within 14 days of the first dose); platelet count (PLT)≥90×109/L （note: PLT≥70 × 109/L for patients with Non-Hodgkin Lymphoma (NHL) and ≥50 × 109/L allowed in patients with bone marrow infiltration. no blood product transfusion is allowed within 14 days of the first dose); hemoglobin (Hb) ≥90g/L (note: Hb ≥80g/L for patients with NHL and ≥70g/L in patients with bone marrow infiltration. no blood product transfusion is allowed within 14 days of the first dose); 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×ULN, Aspartate Amino Tranferase (AST) and Alanine Transaminase (ALT)≤2.5×ULN (note: ≤ 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. Key Exclusion Criteria: * known or suspected allergies to any of the investigational drug compositon. * 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 due to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
Where this trial is running
Hangzhou, Zhejiang
- The first affiliated hospital, Zhejiang university school of medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jie Jin, MD, PhD — Zhejiang University
- 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.