OncoMatch/Clinical Trials/NCT06088888
TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
Is NCT06088888 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TGRX-678 for chronic myelogenous leukemia.
Treatment: TGRX-678 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Disease stage
Required: Stage CML-CP
Diagnosis of CML-CP during the screening period
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: tyrosine kinase inhibitor
Intolerant or resistant to TKI treatments
Cannot have received: antineoplastic therapy
Exposure to other antineoplastic therapies prior to study enrollment
Cannot have received: investigational agent
Exposure to other investigational agent(s) within 14 days of initiating TGRX-678 therapy
Cannot have received: hematopoietic cell transplantation
Hematopoietic cell transplantation < 60 days prior to the first dose
Cannot have received: Traditional Chinese medication or herbal preparations indicated for anti-cancer purposes
Receipt of Traditional Chinese medication or herbal preparations indicated for anti-cancer purposes within 2 weeks prior to the first dose
Cannot have received: major surgery
Reception of major surgery within 14 days prior to the first dose
Lab requirements
Blood counts
Adequate Absolute neutrophil count (ANC), hemoglobin and platelets levels
Kidney function
Adequate renal function
Liver function
Adequate liver function
Cardiac function
Normal corrected QT (QTcF) interval as indicated by electrocardiogram (ECG) screening results; No long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome; Significant or uncontrolled cardiovascular diseases as defined in the full clinical protocol
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; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas MD Anderson Cancer Center · Houston, Texas
- Fred Hutchinson Cancer Center · Seattle, Washington
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