TR128 in Patients With Advanced Solid Tumors

NCT05751356 | Recruiting Phase 1

• 1 other identifier: TR128-CN-PI-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

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 30 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 phase II dose

  Evaluated by safety review committee

  Throughout the study for approximately 2 years

Secondary Outcomes (11)

• AUClast

  within 31 days after the first dose

• AUCinf

  within 31 days after the first dose

• Cmax

  within 31 days after the first dose

• Tmax

  within 31 days after the first dose

• CL/F

  within 31 days after the first dose

Study Arms (1)

TR128

EXPERIMENTAL

Drug: TR128

Interventions

TR128 DRUG

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.

TR128

Eligibility Criteria

• Age: 18 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) ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarapeutics Science Inc.: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilonjiang, 150081, China

RECRUITING

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Study Officials

• Lin Shen, MD, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Shu, MD. BS.

CONTACT

+8613918983465; 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

Model Details: Dose escalation and expansion

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: February 23, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)