Chronic Myelogenous LeukemiaPhase 1NCT06088888
TGRX-678 US Phase I for Chronic Myelogenous Leukemia Patients
A Phase 1 study testing TGRX-678 in people with Chronic Myelogenous Leukemia, run by Shenzhen TargetRx Co., Ltd. at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- TGRX-678
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2024to 29 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Elias Jabbour, MD, 713-792-4764, ejabbour@mdanderson.org
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98102
Vivian Oehler, MD, 206-667-1340, voehler@fredhutch.org
About this study
Official title: An Open-label, Dose Escalation + Dose Expansion Phase 1 Trial to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 Given Orally to Patients With Chronic Myeloid Leukemia Who Are Resistant or Intolerant to TKI Treatments
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.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- TGRX-678
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGRX-678Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| TGRX-678 | Experimental | Subjects to be treated with the investigational drug TGRX-678 Receives: Drug: TGRX-678 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: At end of Dose Escalation part of study, an average of 1 year
Safety profile (DLT)
to record and analyse subjects with dose-limiting toxicities (DLTs)
Measured: Time Frame: DLT: collect during Cycle 1 (28 days)
Safety profile (AEs/SAEs)
to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
Measured: AE and SAE: through completion of the study, an average of 2 years
Recommended phase II dose (RP2D)
To determine the RP2D of TGRX-678 in CML patients for Phase II
Measured: At completion of the study, an average of 2 years
Secondary outcomes (14)
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.
Measured: 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
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.
Measured: at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years
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.
Measured: at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years
Plasma Cmax
Cmax of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Tmax
Tmax of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma T1/2
T1/2 of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma AUClast
AUClast of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma AUCinf
AUCinf of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Cmin
Cmin of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma AUCss
AUCss of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Cmax,ss
steady state Cmax of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Tmax,ss
steady state Tmax of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
CL (Clearance)
Clearance of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Vd (Volume of distribution)
Volume of distribution of TGRX-678 as measured in plasma
Measured: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start2 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Elias Jabbour, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088888
- Sponsor's protocol ID
- TGRX-678-07-101
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose Escalation + Dose Expansion Phase 1 Trial to Determine the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 Given Orally to Patients With Chronic Myeloid Leukemia Who Are Resistant or Intolerant to TKI Treatments
- ClinicalTrials.gov ID
- NCT06088888
- Acronym / sponsor ID
- TGRX-678-07-101
- Conditions
- Chronic Myelogenous Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shenzhen TargetRx Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TGRX-678 | Experimental | Drug: TGRX-678Subjects to be treated with the investigational drug TGRX-678 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGRX-678Participants 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. | Drug | TGRX-678 |
Primary outcome
Recommended dose for expansion (RDE)
Time frame: Time Frame: At end of Dose Escalation part of study, an average of 1 year
To determine the RDE of TGRX-678 in CML patients to be applied in Cohort Expansion part of the study
Safety profile (DLT)
Time frame: Time Frame: DLT: collect during Cycle 1 (28 days)
to record and analyse subjects with dose-limiting toxicities (DLTs)
Safety profile (AEs/SAEs)
Time frame: AE and SAE: through completion of the study, an average of 2 years
to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)
Recommended phase II dose (RP2D)
Time frame: At completion of the study, an average of 2 years
To determine the RP2D of TGRX-678 in CML patients for Phase II
14 secondary outcomes
Hematologic Response
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
Cytogenetic Response
Time frame: at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years
Molecular Response
Time frame: at screening period, end of every 3 Cycles (each cycle is 28 days), an average of 1.5 years
Plasma Cmax
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Tmax
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma T1/2
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma AUClast
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma AUCinf
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Cmin
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma AUCss
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Cmax,ss
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Plasma Tmax,ss
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
CL (Clearance)
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Vd (Volume of distribution)
Time frame: Day 1, 7, 21, 28 of Cycle 1, and Day 28 of Cycle 2, 3 and 5 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elias Jabbour principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TGRX-678 in people with Chronic Myelogenous Leukemia, run by Shenzhen TargetRx Co., Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyi Zhu (86-13061651609, xinyi.zhu@tjrbiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended dose for expansion (RDE) (time frame: Time Frame: At end of Dose Escalation part of study, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.