Recruiting
Phase 1

TGRX-678

Sponsor:

Shenzhen TargetRx, Inc.

Code:

NCT06088888

Conditions

Chronic Myelogenous Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TGRX-678

Study Details

Brief 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.

Conditions

Chronic Myelogenous Leukemia

Study ID

NCT06088888

Start date

Jul 2, 2024

Status verified date

Feb, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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;

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TGRX-678

Subjects to be treated with the investigational drug TGRX-678

Interventions

TGRX-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.

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 ]
  • Safety profile (DLT) [ Time Frame: Time Frame: DLT: collect during Cycle 1 (28 days) ]
  • Safety profile (AEs/SAEs) [ Time Frame: AE and SAE: through completion of the study, an average of 2 years ]
  • Recommended phase II dose (RP2D) [ Time Frame: At completion of the study, an average of 2 years ]

Central Contacts and Locations

Central contacts

Xinyi Zhu

86-13061651609xinyi.zhu@tjrbiosciences.com

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Elias Jabbour, MD

713-792-4764ejabbour@mdanderson.org

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98102

Contacts

Vivian Oehler, MD

206-667-1340voehler@fredhutch.org

More Information

Sponsor

Shenzhen TargetRx, Inc.

Last update posted

Feb 21, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shenzhen TargetRx, Inc. on 2025-02-21.