Clinical Trials List
Protocol NumberDS7300-202
NCT Number(ClinicalTrials.gov Identfier)NCT06644781
Active
2025-02-03 - 2029-01-31
Phase III
Recruiting5
ICD-10C15.3
Malignant neoplasm of upper third of esophagus
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9150.0
Malignant neoplasm of cervical esophagus
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)
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Trial Applicant
Daiichi Sankyo Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 郭弘揚 Division of Hematology & Oncology
- Chia-Chi Lin Division of Hematology & Oncology
- Ta-Ching Chen Division of Ophthalmology
- TA-CHEN HUANG Division of Hematology & Oncology
- 莊建淮 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tai-Jan Chiu Division of Hematology & Oncology
- 黃詩喻 Division of Hematology & Oncology
- 李易濰 Division of Radiology
- 郭明濬 Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
- 林昶廷 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- 蔡宗翰 Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 林偉哲 Division of Radiology
- 黃泰霖 Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林泰祺 Division of Ophthalmology
- 翁章旂 Division of Ophthalmology
- 陳宥任 Digestive System Department
- 姜乃榕 Division of Hematology & Oncology
- 翁敬堯 Division of Radiology
- Yun-Cheng Hsieh Digestive System Department
- Yi-Ping Hung Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
- Chueh-Chuan Yen Division of Hematology & Oncology
- 唐振育 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Jui Yen
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Esophageal Squamous Cell Carcinoma
Objectives
This is a global, multicenter, randomized, open-label, phase III trial for patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following platinum-based systemic therapy and an immune checkpoint inhibitor (ICI). Participants must have previously received no more than one line of systemic therapy for unresectable advanced or metastatic ESCC.
The primary objective of this study is to evaluate the overall survival (OS) benefit of I-DXd compared to investigator-selected chemotherapy (ICC).
Test Drug
Injectable frozen powder
Active Ingredient
Ifinatamab Deruxtecan (I-DXd)
Dosage Form
048
Dosage
100 MG
Endpoints
Evaluate the OS benefits of I-DXd compared to ICC.
OS is defined as the time interval from the randomly assigned date to death from any cause.
OS is defined as the time interval from the randomly assigned date to death from any cause.
Inclution Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria
Exclusion Criteria:
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.
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.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
680 participants
