NCT06644781招募中3 期
A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 161
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).
详细描述
The primary objective of this study is to evaluate the overall survival (OS) benefit of I-DXd compared with investigator's choice of chemotherapy (ICC).
The key secondary objectives of the study will evaluate the progression-free survival (PFS) and objective response rate (ORR) benefit of I-DXd compared with ICC.
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
- •Participants must meet all of the following criteria to be eligible for randomization into the study:
- •Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
- •Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC according to American Joint Committee on Cancer 8th edition staging system on ESCC.
- •Has disease progression post a platinum-based chemotherapy and an ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.
- •The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the Laboratory Manual.
- •Has at least 1 measurable lesion on computed tomography (CT)/magnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the investigator. Measurable lesions should not be from a previously irradiated site. If the lesion at a previously irradiated site is the only selectable target lesion, a radiological assessment showing significant progression of the irradiated lesion should be provided by the investigator.
- •Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.
排除标准
- •Participants who meet any of the following criteria will be disqualified from entering the study:
- •Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
- •Has received any topoisomerase inhibitor.
- •Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
- •Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance.
- •Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of bleeding or fistula as assessed by the investigator.
- •Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and not requiring treatment with corticosteroids or anticonvulsants) may be included in the study. Subjects must have a stable neurologic status and discontinue corticosteroid usage for at least 2 weeks prior to Screening.
- •Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism.
- •Has a clinically significant corneal disease.
- •Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
- •Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study randomization, severe asthma, chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.
- •Is on chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD), topical steroids (for mild skin conditions), or intra-articular steroid injections.
研究组 & 干预措施
Investigator's Choice of Chemotherapy (ICC)
Active Comparator
Participants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).
干预措施: Irinotecan hydrochloride (HCl) (Drug)
Investigator's Choice of Chemotherapy (ICC)
Active Comparator
Participants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).
干预措施: Docetaxel (Drug)
I-DXd
Experimental
Participants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).
干预措施: Ifinatamab deruxtecan (Drug)
Investigator's Choice of Chemotherapy (ICC)
Active Comparator
Participants who are randomized to receive an intravenous infusion of investigator's choice of chemotherapy (docetaxel, paclitaxel, and irinotecan HCl).
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From the date of randomization to the date of death due to any cause, up to approximately 54 months
Overall Survival (OS) is defined as the time interval from the date of randomization to the date of death due to any cause.
次要结局
- Progression-free survival (PFS)(From the date of randomization to the date of disease progression or death due to any cause, whichever occurs first, up to approximately 54 months)
- Objective Response Rate (ORR)(From the time of first dose of study drug until date of documented disease progression or death, whichever occurs first, up to approximately 54 months)
- Duration of Response (DoR)(From the time of the first dose of study drug until the date of documented disease progression (as assessed by BICR) or death due to any cause, up to approximately 54 months)
- Disease Control Rate (DCR)(From the time of the first dose of study drug until the date of documented disease progression (as assessed by BICR) or death due to any cause, up to approximately 54 months)
- Change from baseline in European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Score (EORTC QLQ-C30)(Baseline up to 54 months)
- Change from baseline in European Organisation for Research and Treatment of Cancer Esophageal Cancer Module Score (EORTC OES18)(Baseline up to 54 months)
- Incidence of Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)(Baseline up to 54 months)
- Percentage of Participants Who Have Treatment-emergent ADA(Baseline up to 54 months)
- Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for I-DXd(Cycle 1: Before infusion (BI), end of infusion (EOI), 3 hours (hr), 6hr, 24hr, 72hr, 168hr, 336hr, 504hr postdose; Cycle 2: BI and EOI; Cycle 3: BI, EOI, and 6hr postdose; Cycle 4, 5, & every 2 cycles thereafter, up to 54 mths: BI (each cycle is 21 days))
- Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for Total Anti-B7-H3 Antibody(Cycle 1: Before infusion (BI), end of infusion (EOI), 3 hours (hr), 6hr, 24hr, 72hr, 168hr, 336hr, 504hr postdose; Cycle 2: BI and EOI; Cycle 3: BI, EOI, and 6hr postdose; Cycle 4, 5, & every 2 cycles thereafter, up to 49 mths: BI (each cycle is 21 days))
- Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for MAAA-1181a(Cycle 1: Before infusion (BI), end of infusion (EOI), 3 hours (hr), 6hr, 24hr, 72hr, 168hr, 336hr, 504hr postdose; Cycle 2: BI and EOI; Cycle 3: BI, EOI, and 6hr postdose; Cycle 4, 5, & every 2 cycles thereafter, up to 49 mths: BI (each cycle is 21 days))
研究者
研究点 (161)
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