Can a new pill outsmart Drug-Resistant leukemia?

NCT ID NCT06088888

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Researchers are testing an experimental oral drug called TGRX-678 in adults with chronic myeloid leukemia (CML) whose disease has resisted or not tolerated standard TKI treatments. The phase 1 trial gives participants daily tablets at increasing doses to find a safe dose and to watch for side effects. The team also measures how the body processes the drug and whether it reduces leukemia markers in the blood and bone marrow.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental oral drug called TGRX-678
What this could lead to
If TGRX-678 works, it could offer a new oral option for people whose chronic myeloid leukemia has stopped responding to standard TKI drugs or who cannot tolerate them.
What could go wrong
This is an early phase 1 trial with about 90 participants, so most questions about benefit and long-term safety remain open. The drug may cause side effects or fail to control leukemia in people whose disease has already resisted other treatments.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

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

Started

Jul 2024

Expected to finish

Feb 2028

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 participate in the study with informed consent; * At least 18 years of age at the time of screening; * Any sex; * Diagnosis of CML-CPduring the screening period; * Intolerant or resistant to TKI treatments; * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; * Adequate Absolute neutrophil count (ANC), hemoglobin and platelets levels; * Adequate renal and liver function; * Normal corrected QT (QTcF) interval as indicated by electrocardiogram (ECG) screening results; * Negative blood pregnancy test results for female patients of childbearing potential. * Willing to take highly effective contraceptive measures throughout the trial and for 6 months after last dose of investigational drug for female subjects of child-bearing potential or male subject with female partner of child-bearing potential. Exclusion Criteria: * Exposure to other antineoplastic therapies prior to study enrollment; * Exposure to other investigational agent(s) within 14 days of initiating TGRX-678 therapy; * Ongoing toxicity from prior therapy greater than grade 1 by CTCAE v. 3 (except alopecia); * Hematopoietic cell transplantation \< 60 days prior to the first dose; * Evidence of graft versus host disease (GVHD), whether or not requiring immunosuppressive therapy; * Concomitant immunosuppressive therapy (other than short-term corticosteroid treatment); * Exposure to drugs related to torsade de pointes; * Cytological or pathological diagnosis of active central nervous system disorder; * Significant or uncontrolled cardiovascular diseases as defined in the full clinical protocol; * Having long QT syndrome, or with family history of idiopathic sudden death or congenital long QT syndrome; * Uncontrolled hypertension; * Receipt of Traditional Chinese medication or herbal preparations indicated for anti-cancer purposes within 2 weeks prior to the first dose; * Severe hemorrhagic disorders unrelated to CML; * History of pancreatitis; * History of excessive alcohol use; * History of elevation in amylase or lipase within 1 year; * Have Grade 2 or worse interstitial lung disease or interstitial pneumonitis within 4 weeks prior to Screening; * Uncontrolled hypertriglyceridemia; * Malabsorption syndrome or other illness that could affect oral absorption. * Diagnosis of another primary malignancy in the past 3 years; * Reception of major surgery within 14 days prior to the first dose; * Active infections that require systemic treatment or other severe infections within 14 days prior to enrollment; * Known human immunodeficiency virus (HIV) positive; acute or chronic liver disease (including chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections); * Have received or will receive a COVID-19 vaccine within 14 days of study enrollment; * Have a positive reverse transcriptase polymerase chain reaction (RT-PCR) test result for SARS-CoV-2 within 2 weeks prior to Screening; * Pregnant or breastfeeding female; * Female patient of child-bearing potential or male patient who have female partners of child-bearing potential that is unable or unwilling to take highly effective contraceptive measures during the trial and for 6 months after last dose of investigational drug; * Significant organ dysfunction that could compromise the patient's safety or the evaluation of the drug's safety in the opinion of the investigator or the medical monitor; * Any condition makes participation in this trial inappropriate in the opinion of the investigator or medical monitor;

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98102, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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