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TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE1

TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia

A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects with Refractory or Advanced Chronic Myelogenous Leukemia

NCT06088888•Shenzhen TargetRx Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.

Detailed Description

This is the first trial with TGRX-678 conducted to US patients which aims to evaluate the safety profile and preliminary efficacy profile in advanced or refractory CML patients with previous failure or intolerance to TKI treatments. The primary purpose of this study is to evaluate the safety profile of TGRX-678, including determination of the recommended dose for expansion (RDE) and other safety measures of the investigational drug, such as adverse events and abnormal clinical outcomes. Preliminary efficacy profile of TGRX-678 is evaluated based on the changes in peripheral blood cells and disease-associated cytogenetic and molecular markers. Recommended Phase II dose (RP2D) will be determined at end of the study considering safety, tolerability, pharmacokinetic and efficacy data.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing to participate in the study with informed consent;
•At least 18 years of age at the time of screening;
•Any sex;
•Diagnosis of CML-CPduring the screening period;
•Intolerant or resistant to TKI treatments;
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
•Adequate Absolute neutrophil count (ANC), hemoglobin and platelets levels;
•Adequate renal and liver function;
•Normal corrected QT (QTcF) interval as indicated by electrocardiogram (ECG) screening results;
•Negative blood pregnancy test results for female patients of childbearing potential.
+1 more criteria

Exclusion Criteria

•Exposure to other antineoplastic therapies prior to study enrollment;
•Exposure to other investigational agent(s) within 14 days of initiating TGRX-678 therapy;
•Ongoing toxicity from prior therapy greater than grade 1 by CTCAE v. 3 (except alopecia);
•Hematopoietic cell transplantation \< 60 days prior to the first dose;
•Evidence of graft versus host disease (GVHD), whether or not requiring immunosuppressive therapy;
•Concomitant immunosuppressive therapy (other than short-term corticosteroid treatment);
•Exposure to drugs related to torsade de pointes;
•Cytological or pathological diagnosis of active central nervous system disorder;
•Significant or uncontrolled cardiovascular diseases as defined in the full clinical protocol;
•Having long QT syndrome, or with family history of idiopathic sudden death or congenital long QT syndrome;
+19 more criteria

Locations (2)

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Key Dates

Start Date

July 2, 2024

Primary Completion Date

March 30, 2027

Completion Date

June 30, 2027

Last Updated

February 21, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Myelogenous Leukemia

Interventions

TGRX-678

DRUG

Contacts

Xinyi Zhu

CONTACT

86-13061651609 xinyi.zhu@tjrbiosciences.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia

Inclusion Criteria

Exclusion Criteria

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