---
title: TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients
nct_id: NCT07489755
overall_status: NOT_YET_RECRUITING
phase: PHASE3
sponsor: Shenzhen TargetRx Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Chronic Myelogenous Leukemia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07489755.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07489755"
ct_last_update_post_date: 2026-03-24
last_seen_at: "2026-05-12T07:32:42.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients

**Official Title:** A Randomized, Open-label, Multi-center Phase III Study Evaluating Efficacy and Safety of TGRX-678 Comparing to Investigator Selected Tyrosine Kinase Inhibitor (TKI) in CML-CP Patients Resistant From or Intolerant to at Least 3 TKI Treatments

**NCT ID:** [NCT07489755](https://clinicaltrials.gov/study/NCT07489755)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 180
- **Lead Sponsor:** Shenzhen TargetRx Co., Ltd.
- **Conditions:** Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia - Chronic Phase
- **Start Date:** 2026-04-01
- **Completion Date:** 2031-05-01
- **CT.gov Last Update:** 2026-03-24

## Brief Summary

A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs

## Detailed Description

This Phase III study is of randomized, open-label and multi-center designs to study safety and efficacy profiles of TGRX-678 in CML-CP patients. Patients need to have medical history of failing treatment(s) from at least 3 TKI drugs. Patients with or without T315I mutation is enrolled. Patients are randomized to either TGRX-678 treatment or TKI treatment at investigator's decision.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Willing to consent and to follow study procedures
* 18 years of age or above at time of screening; both sexes eligible
* Diagnosed with CML-CP and was intolerant to or failed from at least 3 TKI treatments
* ECOG score \>= 2
* Adequate hematological indicators and have not used blood products or Colony-Stimulating Factor (CSF)
* Adequate kidney, liver and coagulation 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 other anti-tumor treatments prior to first dose
* History or presence of extramedullary leukemia
* History of progression to CML-AP or BP
* Presence or having uncontrolled condition for cardiovascular diseases
* History of severe hemorrhagic disease
* Presence of malabsorption or other conditions that may affect drug absorption
* History of other primary malignancy within 5 years
* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)
* In need for or having long-term immune suppressive treatment
* Reception of major surgery 28 days before first dose
* Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade \>=1
* Presence of other conditions that the investigators or medical monitor deem unfit for the study
```

## Arms

- **TGRX-678** (EXPERIMENTAL) — Patients randomly assigned to this arm will take TGRX-678 as treatment for CML
- **TKI** (ACTIVE_COMPARATOR) — Patients randomly assigned to this arm will take TKI of investigator's choice as treatment for CML

## Interventions

- **TGRX-678** (DRUG) — Patients will be given TGRX-678 for oral administration
- **TKI** (DRUG) — Patient will take TKI of investigator's choice for oral administration

## Primary Outcomes

- **Event-free survival (EFS)** _(time frame: from randomization to occurance of any of the above-mentioned events (estimated study duration: 5 years))_ — EFS measures time duration between randomization to disease progression, treatment failure, loss of efficacy, development of new mutation, or death, whichever occurs first

## Secondary Outcomes

- **Hematologic Response** _(time frame: From randomization to end of study (estimated study duration: 5 years))_
- **Cytogenetic Response** _(time frame: from randomization to end of study (estimated study duration: 5 years))_
- **Molecular Response** _(time frame: from randomization to end of study (estimated study duration: 5 years))_
- **Progression Free Survival (PFS)** _(time frame: from randomization to end of study (estimated study duration: 5 years))_
- **Overall Survival (OS)** _(time frame: from randomization to end of study (estimated study duration: 5 years))_
- **Treatment Emergent Adverse Event (TEAE)** _(time frame: from randomization to end of study (estimated study duration: 5 years))_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07489755.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07489755*  
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