Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer

Phase 3RecruitingNCT07008976

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.246 enrolled

Overview

This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

246

Conditions

Metastatic Breast Cancer

Interventions

TQB2102 InjectionDRUG

TQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance; * Age: 18 - 75 years old (at the time of signing the informed consent form); Eastern Cooperative Oncology Group (ECOG )score ≤ 1; Expected survival period exceeds 3 months; * HER2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination; * According to the 2018 version of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP )HumanEpidermalGrowthFactorReceptor2 (HER2) testing guidelines, HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive; * The hormone receptor (HR) status has been clearly determined: a) According to the 2020 version of the ASCO/CAP guidelines, HR positive includes ER positive and/or PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%. * Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage. * Disease progression occurred during or after the most recent treatment or intolerance. * At least 1 line of treatment has been received in the recurrence/metastasis stage. * According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, at least one measurable lesion exists. Exclusion Criteria: * Excluded are patients with known spinal cord compression or active central nervous system metastases . * Patients with only skin and/or intracranial lesions as target lesions. * Patients with adverse reactions from previous treatments that have not recovered to a CTCAE v5.0 grade score of ≤1. * Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg). * Patients with major cardiovascular diseases * Patients with a history of interstitial lung disease/pneumonia (non-infectious type) requiring steroid intervention treatment, or currently having interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening period imaging and cannot be excluded.

Outcomes

Primary Outcomes

The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)

The PFS evaluation of TQB2102 for injection compared with Trastuzumab Emtansine for injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the Independent Imaging Review Committee (IRC).

Time frame: Up 30 months

Secondary Outcomes

The PFS evaluated by the researchers

The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine in evaluating the progression-free survival (PFS) in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the researchers.

Time frame: Up 30 months

The Overall Survival (OS) evaluated by the researchers

The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine, as evaluated by the researchers, in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs.

Time frame: Up to 5 years

The Duration of Response (DOR) evaluated by the researchers

The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine as evaluated by the researchers in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was studied.

Time frame: Up to 5 years

The Partial Response (PR) evaluated by the researchers

The efficacy of PR-assessed TQB2102 injection compared with Trastuzumab Emtansine injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was evaluated by the researchers.

Time frame: Up to 5 years

The Objective Response Rate (ORR)evaluated by the researchers

The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine in evaluating the objective response rate (ORR) was assessed in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs.

Time frame: Up to 5 years

The Clinical Benefit Rate (CBR) evaluated by the researchers

The efficacy of CBR evaluated injection TQB2102 compared to injection Trastuzumab Emtansine in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the researchers.

Time frame: Up to 5 years

The incidence and severity of adverse events

The proportion of patients experiencing adverse events, and these adverse events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame: Sign the informed consent form, and until 28 days after the last medication administration / before starting a new anti-tumor treatment (which ever occurs first))

Antibody-drug conjugate (ADC)

Evaluate the population pharmacokinetic (PK) characteristics of TOB2102 for injection in patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs.

Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)

Total antibodies

Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)

The small molecule toxin TO22723

The blood concentration of the small molecule toxin TO22723 in TOB2102.

Time frame: Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks)

The incidence rate of Anti-Drug Antibody (ADA)

Evaluate the immunogenicity of injectable TQB2102 in conditions such as ADA incidence rate. Subjects with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have previously received anti-HER2 monoclonal antibodies and taxane drugs.

Time frame: Cycle 1, Cycle 2, Cycle 4, Cycle 8, Cycle 16, 28 days (±7 days) after the last administration (Each cycle is 3 weeks)

Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer

Overview

Conditions

Interventions

Eligibility

Locations (31)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts