CML ADVOCATES NETWORK

Clinical Trials

TGRX-678 = US Phase I for Subjects With Refractory or Advanced Chronic Myelogenous Leukemia [USA]

Study title

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

Scientific title

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

Type of study

Trial after therapy failure or intolerance; Treatment of advanced phases

Phase

1

Current status

Recruiting

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Other trial ID

TGRX-678-07-101; ClinicalTrials.gov NCT06088888

What is the purpose of the study

TGRX-678 is a new drug under investigation for the treatment of CML.

This is a study to evaluate the safety, tolerability and preliminary efficacy of TGRX-678 in patients with advanced or refractory CML who had failure with or are intolerant to tyrosine kinase inhibitors (TKI). The study will also determine the recommended dose for further clinical evaluation in phase 2, and assess how the body interacts with TGRX-678. In scientific terms, this is called pharmacokinetics.

What will happen during the study

This is the first trial with TGRX-678 conducted in US patients. TGRX-678 will be given once daily as tablets.

 

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged at least 18 years at the time of screening
  • have been diagnosed with chronic myelogenous leukemia in chronic phase (CML-CP) during the screening period
  • are resistant of intolerant to TKI treatments
  • have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
  • have adequate kidney and liver function.

Further criteria apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have been treated with other anticancer therapies prior to study enrollment
  • have been treated with other investigational agent(s) within 14 days of starting treatment with the study drug
  • have adverse reactions related to previous treatment that have not recovered to Grade 1 or lower (except for a specific type of hairloss)
  • have undergone hematopoietic cell transplantation within 60 days of receiving the first dose of the study drug
  • have evidence of graft versus host disease (GVHD), whether or not requiring immunosuppressive therapy
  • are receiving concomitant immunosuppressive therapy (other than short term corticosteroids).

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

March 2027

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by of the U. S. National Institutes of Health.

Study sponsor

Shenzhen TargetRx, Inc. in collaboration with M.D. Anderson Cancer Center

Scientific lead / contact

Xinyi Zhu

Principal investigator

Elias Jabbour, The University of Texas MD Anderson Cancer Center

Study centers / principal investigators

United States

Texas

The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigtor: Elias Jabbour

Washington

Fred Hutchinson Cancer Center
Seattle, Washington, 98102
Principal Investigtor: Vivian Oehler