TR64 in Patients With Advanced Solid Tumors

Official title

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

Overview

This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.

Detailed description

Patients will receive study treatment until criteria for study termination are met. A Safety Follow-up Visit will be conducted 28 days (±7 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 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 RECIST 1.1 criteria, assessed by the investigator.

Interventions

• Drug TR64
  TR64 tablets 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.

Primary outcome measures

• Adverse Events and Serious Adverse Events [Time frame: From the first dose to within 28 days after the last dose]
• Dose limited toxicities [Time frame: within 28 days after the first dose]
• Maximum tolerated dose [Time frame: Throughout the study for approximately 2 years]
• Recommended phaseII dose [Time frame: Throughout the study for approximately 2 years]

Secondary outcome measures (7)

• AUClast [Time frame: within 35 days after the first dose]
• AUCinf [Time frame: within 35 days after the first dose]
• Cmax [Time frame: within 35 days after the first dose]
• Tmax [Time frame: within 35 days after the first dose]
• CL/F [Time frame: within 35 days after the first dose]
• Vz/F [Time frame: within 35 days after the first dose]
• Terminal half-life (T1/2) [Time frame: within 35 days after the first dose]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• The First Affiliated Hospital of Bengbu Medical College — Bengbu
• The First Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT05649345 · TR64-CN-PI-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗