TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients

NCT ID: NCT06453902

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2028-04-30

Brief Summary

A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment

Detailed Description

This Phase II study is of single-arm, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-AP patients. Patients need to have medical history of failing treatment(s) from third-generation TKI drugs. Patients with or without T315I mutation is enrolled.

Conditions

Chronic Myeloid Leukemia; Accelerated Phase CML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: TGRX-678

All patients with CML-AP to be treated with TGRX-678. Patients with T315I mutation or without T315I mutation will be assigned into separate cohorts for evaluation

Group Type: EXPERIMENTAL

TGRX-678

Intervention Type: DRUG

All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally

Interventions

TGRX-678

All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

Tongji Medical College,Huazhong University of Science &Techonlogy

UNKNOWN

Sponsor Role: collaborator

Shenzhen TargetRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qian Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingkun Lu

Role: CONTACT

yingkun.lv@tjrbiosciences.com

18602219981

Facility Contacts

Qian Jiang, MD

Role: primary

Jiangqian@medmail.com

010-88326666

Other Identifiers

TGRX-678-2001

Identifier Type: -

Identifier Source: org_study_id