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

NCT ID: NCT06672263

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-12-31

Brief Summary

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

Conditions

Chronic Myelogenous Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3911 tablets

Once a day for 28 days as a treatment cycle

Group Type: EXPERIMENTAL

TQB3911 tablets

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Qian Jiang, Doctor

Role: CONTACT

jiangqian@medmail.com.cn

010-88326850

Facility Contacts

Li Zhou, Doctor

Role: primary

13816510379Lizhou999_999@126.com

13816510379

Jian Huang, Doctor

Role: primary

13588010568

YanLi Zhang, Doctor

Role: primary

13203729690@163.com

13203729690

ZhenFang Liu, Doctor

Role: primary

liuliuzhenfang@163.com

13481082237

Other Identifiers

TQB3911-I-01

Identifier Type: -

Identifier Source: org_study_id