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Starting soon Phase 1

A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia

NCT06672263 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2024-11
Last updated
2024-11-04

Condition(s) studied

Chronic Myelogenous Leukemia

Investigational drug(s) / intervention(s)

TQB3911 tablets

TQB3911 tablets: TQB3911 is a small molecule BCR::ABL1 allosteric inhibitor. By occupying the myristyl binding site, TQB3911 recovers the inhibition of BCR::ABL1 fusion protein kinase activity, and ultimately inhibits the proliferation of tumor cells.

Study summary

Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Phase II recommended doses (RP2D) — Baseline up to 24 months
    The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).
  • Dose-limiting toxicity (DLT) — Up to 1 month
    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.

Trial sites (5)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Henan Cancer Hospital Zhengzhou Henan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672263 on ClinicalTrials.gov ↗ ← All trials in China