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RecruitingNCT06088888Updated Oct 20, 2026

TGRX-678 US Phase I for Chronic Myelogenous Leukemia Patients

A Phase 1 interventional study of TGRX-678 in Chronic Myelogenous Leukemia, sponsored by Shenzhen TargetRx Co., Ltd.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Shenzhen TargetRx Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Updated Oct 20, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.

Read the detailed description

This is the first trial with TGRX-678 conducted to US patients which aims to evaluate the safety profile and preliminary efficacy profile in advanced or refractory CML patients with previous failure or intolerance to TKI treatments. The primary purpose of this study is to evaluate the safety profile of TGRX-678, including determination of the recommended dose for expansion (RDE) and other safety measures of the investigational drug, such as adverse events and abnormal clinical outcomes. Preliminary efficacy profile of TGRX-678 is evaluated based on the changes in peripheral blood cells and disease-associated cytogenetic and molecular markers. Recommended Phase II dose (RP2D) will be determined at end of the study considering safety, tolerability, pharmacokinetic and efficacy data.

02

Conditions studied

  • Chronic Myelogenous Leukemia
03

In context

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

982 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.

This study's planned enrollment of 90 is above the median of 43 across 755 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →

Lead sponsor

Shenzhen TargetRx Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    TGRX-678

    Subjects to be treated with the investigational drug TGRX-678

    Drug: TGRX-678

Interventions

  • DrugTGRX-678

    Participants are given TGRX-678 tablets orally, once daily, at one of the dose levels as pre-determined for the dose escalation sequence or expansion cohorts.

06

What researchers measure

Primary outcomes

  1. Recommended dose for expansion (RDE)

    To determine the RDE of TGRX-678 in CML patients to be applied in Cohort Expansion part of the study

    Time frame: Time Frame: At end of Dose Escalation part of study, an average of 1 year

  2. Safety profile (DLT)

    to record and analyse subjects with dose-limiting toxicities (DLTs)

    Time frame: Time Frame: DLT: collect during Cycle 1 (28 days)

  3. Safety profile (AEs/SAEs)

    to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: AE and SAE: through completion of the study, an average of 2 years

  4. Recommended phase II dose (RP2D)

    To determine the RP2D of TGRX-678 in CML patients for Phase II

    Time frame: At completion of the study, an average of 2 years

Secondary outcomes

  1. Hematologic Response

    To record and analyse the hematologic response of subjects. Subjects will be determined whether complete hematologic response (CHR) or no evidence of leukemia (NEL) is reached.

    Time frame: at screening period, weekly in Cycle 1, bi-weekly in Cycle 2 and monthly starting from Cycle 3 (each cycle is 28 days), an average of 1.5 years

  2. Cytogenetic Response

    To record and analyse the cytogenetic response of subjects subjects will be determined whether partial or complete cytogenetic response (Ph+ \< 35%) is reached.

    Time frame: at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years

  3. Molecular Response

    To record and analyse the molecular response of subjects Subjects will be determined whether major molecular response (BCR-ABL1 (IS) no more than 0.1%) is reached.

    Time frame: at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years

  4. Plasma Cmax

    Cmax of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  5. Plasma Tmax

    Tmax of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  6. Plasma T1/2

    T1/2 of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  7. Plasma AUClast

    AUClast of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  8. Plasma AUCinf

    AUCinf of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  9. Plasma Cmin

    Cmin of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  10. Plasma AUCss

    AUCss of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  11. Plasma Cmax,ss

    steady state Cmax of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  12. Plasma Tmax,ss

    steady state Tmax of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  13. CL (Clearance)

    Clearance of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

  14. Vd (Volume of distribution)

    Volume of distribution of TGRX-678 as measured in plasma

    Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)

07

Study locations

2 of 2 sites recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • Fred Hutchinson Cancer Center
    Seattle, Washington 98102, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2027, 41 months after the start.

Of 57 phase 1 interventional studies under Leukemia, Myelogenous, Chronic, BCR-ABL Positive, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 104. This study's planned 41 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Mar 2027 → Dec 2027 and completion Jun 2027 → Feb 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2023
First posted
Oct 18, 2023
StartActual
Jul 2, 2024
Primary completionEst.
Dec 31, 2027was Mar 2027
CompletionEst.
Feb 29, 2028was Jun 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Mar 30, 2027→Dec 31, 2027
Oct 20, 2026
Study completion
Jun 30, 2027→Feb 29, 2028
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Primary completion Mar 30, 2027→Dec 31, 2027
    Study completion Jun 30, 2027→Feb 29, 2028
    + 3 other changes: identifiers, verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06088888
Lead sponsor
Shenzhen TargetRx Co., Ltd.
Collaborators
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Oct 18, 2023
Start date
Jul 2, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Feb 29, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Xinyi Zhu
Contact
xinyi.zhu@tjrbiosciences.com
86-13061651609
Elias Jabbour
principal investigator · M.D. Anderson Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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