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New hope for Drug-Resistant leukemia: phase 3 trial launches

NCT ID NCT07489755

Disease control Sponsor: Shenzhen TargetRx Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, TGRX-678, in adults with chronic-phase chronic myeloid leukemia (CML) whose cancer has stopped responding to or caused side effects from at least three prior treatments. Participants will receive either TGRX-678 or another standard drug chosen by their doctor. The main goal is to see if TGRX-678 can delay disease progression or death better than current options.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myelogenous leukemia Chronic myelogenous leukemia - chronic phase

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.