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

NCT06672263 | Not Yet Recruiting Phase 1

• 1 other identifier: TQB3911-I-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (2)

• Phase II recommended doses (RP2D)

  The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).

  Baseline up to 24 months

• Dose-limiting toxicity (DLT)

  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.

  Up to 1 month

Secondary Outcomes (10)

• Incidence and severity of adverse event (AE) and serious adverse event (SAE), and abnormal laboratory test indicators

  From the signing of informed consent for administration to 28 days after the last administration/start of the new antitumor therapy (whichever occurs first).

• Peak time

  Single dose on days 1 to 3, day 8 of cycle 1, day 15 of cycle 1, day 22 of cycle 1, and day 2 to day 1, each cycle is 28 days.

• C-QT Research

  Single dose: 1 hour, 0.5 hour, 10 minutes before dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours after dose.

• Platelet count

  For the first six weeks, the assessment was weekly. Starting at week 6, assessments were performed at week 8 and every 4 weeks (±7 days) thereafter

• The proportion of Philadelphia chromosomes in the metaphase of bone marrow cells

  They were evaluated every 12 weeks (±7 days) for 96 weeks and every 24 weeks (±7 days) after 96 weeks

Study Arms (1)

TQB3911 tablets

EXPERIMENTAL

Once a day for 28 days as a treatment cycle

Drug: TQB3911 tablets

Interventions

TQB3911 tablets 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.

TQB3911 tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qian Jiang, Doctor

CONTACT

010-88326850; jiangqian@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: November 4, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-07

Locations

CN (5)