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临床试验/NCT06926868
NCT06926868招募中2 期

IZABRIGHT-Breast01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Bristol-Myers Squibb553 个研究点 分布在 3 个国家目标入组 600 人开始时间: 2025年9月11日最近更新:
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干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
600
试验地点
553
主要终点
Progression-Free Survival (PFS)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria, based on the most recently analyzed biopsy or other pathology specimen.
  • •Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
  • •Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab) due to any one of the following criteria:
  • •i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of standard of care (SoC); ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication, in the opinion of the investigator, for the use of an anti-PD(L)1 drug: iv) Any auto-immune disease that requires current immunosuppression (eg, methotrexate, cyclophosphamide, prednisone > 10 mg/day).
  • •v) Prior auto-immune AE to peri-adjuvant ICI that required immunosuppression. vi) Current Graves' disease with ophthalmopathy or in need of radioiodine or in use of antithyroid medication.
  • •vii) Current or prior auto-immune diseases per below: A. Moderate to severe rheumatoid arthritis. B. Auto-immune hepatitis or cholangitis. C. Myasthenia gravis. D. Moderate-to-severe or poorly controlled inflammatory bowel disease. E. Multiple sclerosis. F. Lupus with kidney involvement or moderate to severe lupus. G. Auto-immune myocarditis. Note: if participant meets Inclusion Criteria 5b or 5c, unknown PDL1 results per local SOC are acceptable in these specific cases.
  • •Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
  • •No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
  • •Measurable disease by CT or MRI as per RECIST v1.1.

排除标准

  • •Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi).
  • •Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants' neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy.
  • •Leptomeningeal metastases.
  • •Participants with history of severe heart disease including, but not limited to, any of the following:
  • •i) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, pericarditis, or significant pericardial effusion).
  • •ii) Myocardial infarction, uncontrolled angina, or stroke/transient ischemic attack within the past 6 months.
  • •iii) QTc (by Fridericia's formula) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block.
  • •iv) Known LVEF < 50%.
  • •Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload.
  • •Other protocol-defined Inclusion/Exclusion criteria apply.

研究组 & 干预措施

Arm A1

Experimental

干预措施: Iza-bren (Drug)

Arm A2

Experimental

干预措施: Iza-bren (Drug)

Arm B

Active Comparator

干预措施: Nab-paclitaxel (Drug)

Arm B

Active Comparator

干预措施: Capecitabine (Drug)

Arm B

Active Comparator

干预措施: Carboplatin (Drug)

Arm B

Active Comparator

干预措施: Gemcitabine (Drug)

Arm B

Active Comparator

干预措施: Paclitaxel (Drug)

结局指标

主要结局

Progression-Free Survival (PFS)

时间窗: Approximately 22 months from first participant randomization in Phase 3

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)

Recommended Phase 3 Dose (RP3D) of BMS-986507

时间窗: Approximately 13 months from first participant randomization in Phase 2

Progression-Free Survival (PFS)

时间窗: Approximately 31 months from first participant randomization

Assessed using Response Evaluation Criteriain Solid Tumors version 1.1 (RECIST v1.1) byblinded independent central review (BICR)

次要结局

  • Overall Survival (OS)(Approximately up to 57 months from first participant randomization)
  • Recommended Phase 3 Dose (RP3D) of BMS-986507(Approximately 19 months from first participant randomization)
  • Number of participants with treatment-related Adverse Events (AEs)(Approximately up to 57 months from first participant randomization)
  • Number of participants with laboratory abnormalities(Approximately up to 57 months from first participant randomization)
  • Number of participants with serious AEs (SAEs)(Approximately up to 57 months from first participant randomization)
  • Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay(Approximately up to 57 months from first participant randomization)
  • Number of deaths(Approximately up to 57 months from first participant randomization)
  • Objective Response (OR)(Approximately 31 months from first participant randomization)
  • PFS(Approximately 31 months from first participant randomization)
  • Disease control rate (DCR)(Approximately 31 months from first participant randomization)
  • Duration of Response (DOR)(Approximately 31 months from first participant randomization)
  • Time to Response (TTR)(Approximately 31 months from first participant randomization)
  • Time to subsequent treatment (TTST)(Approximately up to 57 months from first participant randomization)
  • Progression-free survival after next line of treatment (PFS2)(Approximately up to 57 months from first participant randomization)
  • Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Approximately up to 57 months from first participant randomization)
  • Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)(Approximately up to 57 months from first participant randomization)
  • Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score(Approximately up to 57 months from first participant randomization)
  • Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)(Approximately up to 57 months from first participant randomization)
  • Overall Survival (OS)(Approximately up to 47 months from first participant randomization in Phase 3)
  • Number of participants with treatment-related Adverse Events (AEs)(Approximately up to 47 months from first participant randomization in Phase 3)
  • Number of participants with laboratory abnormalities(Approximately up to 47 months from first participant randomization in Phase 3)
  • Number of participants with serious AEs (SAEs)(Approximately up to 47 months from first participant randomization in Phase 3)
  • Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay(Approximately up to 47 months from first participant randomization in Phase 3)
  • Number of deaths(Approximately up to 47 months from first participant randomization in Phase 3)
  • Objective Response (OR) per BICR(Approximately 22 months from first participant randomization in Phase 3)
  • Objective Response (OR) per Investigator(Approximately 22 months from first participant randomization in Phase 3)
  • PFS rate(Approximately 22 months from first participant randomization in Phase 3)
  • Relative change in tumor size(Approximately 22 months from first participant randomization in Phase 3)
  • Disease control rate (DCR) per BICR(Approximately 22 months from first participant randomization in Phase 3)
  • Disease control rate (DCR) per Investigator(Approximately 22 months from first participant randomization in Phase 3)
  • PFS(Approximately 22 months from first participant randomization in Phase 3)
  • Duration of Response (DOR) per BICR(Approximately 22 months from first participant randomization in Phase 3)
  • Duration of response (DOR) per Investigator(Approximately 22 months from first participant randomization in Phase 3)
  • Time to Response (TTR) per BICR(Approximately 22 months from first participant randomization in Phase 3)
  • Time to response (TTR) per Investigator(Approximately 22 months from first participant randomization in Phase 3)
  • Time to subsequent treatment (TTST) per Investigator(Approximately up to 47 months from first participant randomization in Phase 3)
  • Progression-free survival after next line of treatment (PFS2)(Approximately up to 47 months from first participant randomization in Phase 3)
  • Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Approximately up to 47 months from first participant randomization in Phase 3)
  • Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)(Approximately up to 47 months from first participant randomization in Phase 3)
  • Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score(Approximately up to 47 months from first participant randomization in Phase 3)
  • Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)(Approximately up to 47 months from first participant randomization in Phase 3)
  • PFS rate(Approximately 19 months from first participant randomization)
  • Relative change in tumor size(Approximately up to 19 months from first participant randomization)
  • ORR by RECIST v1.1 per Investigator(Approximately 31 months from first participant randomization)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (553)

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