Evaluating TGRX-678 for patients with Chronic Myelogenous Leukemia

A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment

This study is testing a new drug called TGRX-678 to see if it can help people with Chronic Myelogenous Leukemia who haven’t responded to other treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenzhen TargetRx Co., Ltd. (industry)
• Drugs / interventions: Olverembatinib, Ponatinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06453902 on ClinicalTrials.gov

What this trial studies

This Phase II study is designed to assess the safety and efficacy of TGRX-678 in patients with Chronic Myelogenous Leukemia (CML) in the Accelerated Phase who have relapsed or are refractory to third-generation Tyrosine Kinase Inhibitor (TKI) treatments. It is a single-arm, open-label, multi-center trial that includes patients with or without the T315I mutation. Participants must have a documented history of treatment failure with third-generation TKIs and meet specific health criteria to ensure their eligibility for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory CML in the Accelerated Phase after failing third-generation TKI treatments.

Not a fit: Patients who have not received prior treatment with third-generation TKIs or those with other types of leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced CML who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches in treating CML, but the specific use of TGRX-678 is novel.

Eligibility criteria

Inclusion Criteria:

* Willing to consent
* 18 years of age or above at time of screening; both sexes eligible
* Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment
* For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI
* For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment
* Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests
* ECOG score \</=2
* Minimum life expectancy of at least 3 months
* Adequate hematological indicators
* Adequate kidney function
* Adequate liver function
* Adequate coagulation function
* Adequate pancreatic function
* Adequate QTc interval as confirmed by electrocardiogram (ECG) test
* Negative pregnancy result at screening for female patients of child-bearing potential
* Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)

Exclusion Criteria:

* Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose
* Reception of other anti-tumor treatments
* In need for immune suppressive treatment
* Usage of drugs associated with Torsades de Pointes within 1 months before screening
* Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug
* History of hemapoietic stem cell transplant
* Presence of active central nervous system conditions
* CML-AP patients who already reached major hematological response
* CML-AP patients who used to progress to Blast Phase (BP)
* Presence or having uncontrolled condition for cardiovascular diseases
* History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160/100 mmHg for 1 months before screening)
* Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose
* Severe hemorrhagic disease unrelated to CML
* History of severe cardiovascular condition during past TKI treatment for CML
* History of pancreatic inflammation or alcohol abuse within 3 years before first dose
* Uncontrolled Hypertriglyceridemia
* Presence of malabsorption or other conditions that may affect drug absorption
* Diagnosis of other primary malignant tumor within 5 years
* Reception of major surgery 14 days before first dose
* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)
* Presence of other conditions that the investigators or medical monitor deem unfit for the study

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Qian Jiang, MD — Peking University People's Hospital
• Study coordinator: Yingkun Lu

Conditions: Chronic Myeloid Leukemia, Accelerated Phase CML