TR64 in Patients With Advanced Solid Tumors

NCT ID: NCT05649345

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2026-12-30

Brief Summary

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TR64

Daily doses by oral administration on each day of each 28 day cycle. Starting dose is 25mg, with escalation to 400mg, and subsequent dose escalation using a modified Fibonacci algorithm.

Group Type: EXPERIMENTAL

TR64

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tarapeutics Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huan Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Bengbu Medical University

Funan Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status: RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Shu, MD. BS.

Role: CONTACT

shuyang@tarapeutics.com

86-13918983465

Facility Contacts

Huan Zhou, Ph.D

Role: primary

zhouhuanbest@vip.163.com

13665527160

Funan Liu, MD Ph.D

Role: primary

lfn_clinical@126.com

13609877906

Other Identifiers

TR64-CN-PI-01

Identifier Type: -

Identifier Source: org_study_id