TR64 in Patients With Advanced Solid Tumors

NCT05649345 | Recruiting Phase 1

• 1 other identifier: TR64-CN-PI-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Adverse Events and Serious Adverse Events

  Frequency, duration and severity of Adverse Events and Serious Adverse Events evaluated by NCI CTCAE v5.0

  From the first dose to within 28 days after the last dose

• Dose limited toxicities

  Incidence of dose limited toxicities

  within 28 days after the first dose

• Maximum tolerated dose

  Evaluated by safety review committee

  Throughout the study for approximately 2 years

• Recommended phaseII dose

  Evaluated by safety review committee

  Throughout the study for approximately 2 years

Secondary Outcomes (7)

• AUClast

  within 35 days after the first dose

• AUCinf

  within 35 days after the first dose

• Cmax

  within 35 days after the first dose

• Tmax

  within 35 days after the first dose

• CL/F

  within 35 days after the first dose

Other Outcomes (4)

• ORR

  Throughout the study for approximately 2 years

• PFS

  Throughout the study for approximately 2 years

• DOR

  Throughout the study for approximately 2 years

Study Arms (1)

TR64

EXPERIMENTAL

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.

Drug: TR64

Interventions

TR64 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.

TR64

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarapeutics Science Inc.: lead

Study Sites (2)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

Study Officials

• Huan Zhou, PhD

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• Funan Liu, MD, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Shu, MD. BS.

CONTACT

86-13918983465; shuyang@tarapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 14, 2022
• Study Start: January 12, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)