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

NCT06453902 | Recruiting Phase 2

• 1 other identifier: TGRX-678-2001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Myeloid Leukemia; Accelerated Phase CML

Outcome Measures

Primary Outcomes (1)

• Major Hematologic Response (MaHR)

  Number of patients who reached, and rate of occurence of major hematologic response, including those who reached complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR and NEL are defined per China national treatment guideline for CML (ver. 2022). Indicators for hematologic responses will be obtained via peripheral blood tests.

  At screening, on Day 1 of every treatment cycle (each cycle is 28 days) and at end of treatment; average of study duration is 3.5 years

Secondary Outcomes (7)

• Cytogenetic Response

  At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years

• Major Molecular Response (MMR)

  At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years

• Time to Response (TTR)

  At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years

• Duration of Response (DOR)

  At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years

• Progression Free Survival (PFS)

  At screening, on Day 1 of cycle 2, cycle 4 and every 3 cycles afterwards of the treatment cycle (each cycle is 28 days) and at the end of treatment; average of study duration is 3.5 years

Study Arms (1)

Experimental: TGRX-678

EXPERIMENTAL

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

Drug: TGRX-678

Interventions

TGRX-678 DRUG

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

Experimental: TGRX-678

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen TargetRx, Inc.: lead
• Peking University People's Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Chinese Academy of Medical Sciences: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Shenzhen Second People's Hospital: collaborator
• Ruijin Hospital: collaborator
• Shengjing Hospital: collaborator
• Tongji Medical College,Huazhong University of Science &Techonlogy: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Accelerated Phase

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qian Jiang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingkun Lu

CONTACT

18602219981; yingkun.lv@tjrbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 12, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CN (1)