TR128 in Patients With Advanced Solid Tumors

Trial Title: TR128 in Patients With Advanced Solid Tumors

NCT ID: NCT05751356

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Dose escalation and expansion

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TR128
Description: 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.
Arm group label: TR128

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.

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.

Criteria for 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) ≤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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Status: Recruiting

Contact:
Last name: LIN SHEN, M.D.

Phone: +86 13911219511
Email: linshenpku@163.com

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Zip: 150081
Country: China

Status: Recruiting

Contact:
Last name: YANQIAO ZHANG, M.D.

Phone: +86 451-85718890
Email: yanqiaozhang@126.com

Facility:
Name: Tianjin Medical University Cancer Institute&Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Status: Recruiting

Contact:
Last name: TING DENG, M.D.

Phone: +86 18920193527
Email: xymcdengting@126.com

Start date: February 23, 2024

Completion date: December 30, 2025

Lead sponsor:
Agency: Tarapeutics Science Inc.
Agency class: Industry

Source: Tarapeutics Science Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05751356