A Randomized, Open-label, Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy as First-line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of ESG401 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer.
详细描述
This is a randomized, open-label, multicenter Phase 3 study to evaluate ESG401 versus Investigator's Choice Chemotherapy (ICC) as first-line treatment in subjects with unresectable recurrent or metastatic triple-negative breast cancer.
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
- •Males or females aged ≥ 18 years ;
- •Histologically and/or cytologically confirmed TNBC;
- •De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent;
- •No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease;
- •Participants whose tumours are PD-L1-negative, or Participants whose tumours are PD-L1-positive and have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer, or comorbidities precluding PD-1/PD-L1 inhibitor therapy;
- •Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator;
- •At least one measurable lesion per RECIST v1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;
- •A life expectancy of at least 12 weeks;
- •Adequate organ and bone marrow function.
排除标准
- •Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.
- •Toxicities from prior anti-tumor therapy not recovering to ≤ Grade
- •Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.
- •New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.
- •Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
- •Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.
- •Patients with uncontrollable systemic diseases.
- •Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea.
- •Subjects with clinically significant cardiovascular disease.
- •Human Immunodeficiency Virus (HIV) infection.
- •Active hepatitis B or hepatitis C.
- •Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient.
- •Pregnant or lactating women.
研究组 & 干预措施
ESG401 for injection
IV infusion on day 1, 8 and15 of each 28 day cycle
干预措施: ESG401 (Drug)
Investigator's Choice Chemotherapy
If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel. Note: If subjects are intolerant or contraindicated to receive paclitaxel or albumin-paclitaxel, the investigator may choose other chemotherapy options listed in the study protocol) If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin
干预措施: Investigator's Choice Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
时间窗: Randomization up to approximately 28 months
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Overall Survival (OS)
时间窗: Randomization up to approximately 41 months
Defined as the time from randomization until the date of death due to any cause.
次要结局
- Progression-Free Survival (PFS) assessed by Investigator(Randomization up to approximately 28 months)
- Objective Response Rate (ORR) assessed by Blinded Independent Central Review (BICR)(Randomization up to approximately 28 months)
- Disease control rate (DCR) assessed by Blinded Independent Central Review (BICR)(Randomization up to approximately 28 months)
- Quality of life evaluated using the NCC-BC-A scale(Randomization up to approximately 28 months)
- Adverse events(AEs) and severe adverse events (SAEs)(From signing the ICF up to last dose plus 30 days)
- Duration of Response (DoR) assessed by Blinded Independent Central Review (BICR)(Randomization up to approximately 28 months)
- Clearance(Randomization up to approximately 28 months)
- Time to Response (TTR) assessed by Blinded Independent Central Review (BICR)(Randomization up to approximately 28 months)
- Objective Response Rate (ORR) assessed by Investigator(Randomization up to approximately 28 months)
- Disease control rate (DCR) assessed by Investigator(Randomization up to approximately 28 months)
- Duration of Response (DoR) assessed by Investigator(Randomization up to approximately 28 months)
- Time to Response (TTR) assessed by Investigator(Randomization up to approximately 28 months)
- Volume of distribution(Randomization up to approximately 28 months)
- Anti-drug Antibodies(Randomization up to approximately 28 months)