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New treatment option for Chronic Myelogenous Leukemia
Official title TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
ClinicalTrials.gov ID: NCT06088888
What this study is testing
What is TGRX-678?
TGRX-678 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic myelogenous leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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);
See the full eligibility 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 people of child-bearing potential or male subject with female partner of...
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.