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
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
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)
| Facility | City | Region | Status |
| 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 |
|
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition