Can a new pill outsmart Drug-Resistant leukemia?
NCT ID NCT06088888
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98102, United States
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The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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