Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05751356

TR128 in Patients With Advanced Solid Tumors

Led by Tarapeutics Science Inc. · Updated on 2024-05-14

50

Participants Needed

3

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

TR128 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand and voluntarily agree to participate with signed informed consent
  • Male or female at least 18 years old
  • Histologically or cytologically confirmed advanced malignant solid tumors
  • Failed standard treatment, no standard treatment, or unsuitable for standard treatment
  • Measurable disease with at least one lesion assessable by RECIST 1.1
  • ECOG performance status 0 or 1
  • Life expectancy of at least 3 months
  • Acceptable organ function including neutrophils, platelets, hemoglobin, coagulation, liver and kidney function
  • Agree to use medically approved contraceptives during study and 6 months after last dose (if fertile)
Not Eligible

You will not qualify if you...

  • Medical or surgical history excluding participation as defined by protocol
  • Previous medical treatment history excluding participation as defined by protocol
  • Abnormal laboratory results excluding participation as defined by protocol
  • Pregnant or breastfeeding women (currently or within 6 months after delivery)
  • Judged unsuitable for the study by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

2

Harbin Medical University Cancer Hospital

Harbin, Heilonjiang, China, 150081

Actively Recruiting

3

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

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Research Team

Y

Yang Shu, MD. BS.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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