Clinical trial · Interventional
A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia
Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia
NCT06672263CI-TRIAL-00082202not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB3911 tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQB3911 tablets
- description
- Once a day for 28 days as a treatment cycle
- interventionNames
- Drug: TQB3911 tablets
Primary outcomes (2)
- measure
- Phase II recommended doses (RP2D)
- timeFrame
- Baseline up to 24 months
- description
- The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Up to 1 month
- description
- Adverse events that meet the protocol definition of dose-limiting toxic event timing were evaluated according to the Common Terminology Criteria for Adverse Events 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subjects voluntarily joined the study, signed the informed consent, and had good compliance; * Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months; * During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination; * Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure) * The main organs function well * Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period. Exclusion Criteria: * Had or was currently suffering from other malignant tumors within 5 years before the first medication * Combined with active central nervous system leukemia * Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment * Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block * Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication * History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia * Patients with CML-CP who have achieved complete cytogenetic response (CCyR) * Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation * Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period
References
Publications (0)
Data not yet available
No reference posted for this study.