Evaluating TR64 for patients with advanced solid tumors

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 study is testing a new treatment called TR64 to see if it is safe and tolerable for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tarapeutics Science Inc. (industry)
• Locations: 2 sites (Bengbu, Anhui and 1 other locations)
• Trial ID: NCT05649345 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial is an open-label, dose escalation study designed to assess the safety and tolerability of TR64 in patients with advanced solid tumors. The study will utilize a 3+3 design to determine the recommended phase 2 dose (RP2D) of TR64, with patients receiving treatment until specific termination criteria are met. Tumor responses will be evaluated using imaging techniques such as CT or MRI, and adverse events will be monitored according to established criteria. Follow-up visits will occur after treatment to assess patient outcomes and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced solid tumors who have failed or are not suitable for standard treatment.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: Other studies evaluating novel treatments for advanced solid tumors have shown promise, but the specific approach of TR64 is relatively novel.

Eligibility 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) ≤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.

Exclusion Criteria:

* 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.

Where this trial is running

Bengbu, Anhui and 1 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (RECRUITING)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Principal investigator: Huan Zhou, PhD — The First Affiliated Hospital of Bengbu Medical University
• Study coordinator: Yang Shu, MD. BS.

Conditions: Advanced Solid Tumor