TGRX-678 = Chinese Phase I in Chronic Myelogenous Leukemia (CML) Patients [China]

Study title

Chinese Phase I in Chronic Myelogenous Leukemia (CML) Patients

Scientific title

A Single-arm, Open-label, Dose Escalation and Dose Expansion Phase 1 Trial to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Patients With Refractory or Advanced CML

Type of study

Trial after therapy failure or intolerance

Phase

1

Current status

Recruiting

Other trial ID

ClinicalTrials.gov NCT05434312

What is the purpose of the study

This is a study to evaluate the safety, tolerability and preliminary efficacy of TGRX-678 in patients with CML who had failure with or are intolerant to tyrosine kinase inhibitors (TKI). The study also assesses 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 to investigate TGRX-678 in humans.

TGRX-678 is a new drug under investigation for the treatment of CML. TGRX-678 will be given as tablets. The dose will be escalated to determine the recommended dose for further clinical evaluation in patients with chronic phase CML.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged at least 18 years and at the most 75 years at the time of screening
  • have been diagnosed with chronic myelogenous leukemia in chronic phase (CML-CP)
  • have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
  • have been treated with imatinib, dasatinib or nilotinib and are intolerant or resistant to the above drugs according to MD Anderson or ELN guidelines.

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 a tTKI within 7 days of receiving the first dose of 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 received other anticancer therapies and either of the following:
    hydroxyurea or anagrelide within 24 h prior to the first dose; interferon or immunotherapy within 14 days prior to the first dose, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy (excluding any TKI therapy) within 28 days prior to the first dose
  • have undergone stem cell transplant within 60 days of receiving the study drug, have evidence of graft versus host disease (GVHD) or GVHD 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

December 2024

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.

Scientific lead / contact

Principal investigator

Qian Jiang, MD, Peking University People’s Hospital

Study centers / principal investigators

China

Peking University People’s Hospital
Beijing, 100044
PrincipaI Investigator: Qian Jiang, MD