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A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
EU CTIS ID: 2023-509630-19-00
What this study is testing
To evaluate the OS benefit of I-DXd compared with investigator’s choice of chemotherapy (ICC)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects 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
- Has disease progression post platinum-based and ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.
- The subject must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
- Has at least 1 measurable lesion on computed tomography (CT)/ magnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the investigator.
- Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.
You likely can't join if
- Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
- 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.
- Has received any topoisomerase inhibitor.
- Has histologically or cytologically confirmed adenosquamous carcinoma subtype or neuroendocrine features in >30% of tumor tissue.
- Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance. Subjects who received paclitaxel or docetaxel in definitive chemoradiotherapy or neoadjuvant/adjuvant treatment (chemotherapy or chemoradiotherapy) settings whose disease progressed after 6 months of treatment completion are eligible.
See the full eligibility criteria
Who can join
- Subjects 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
- Has disease progression post platinum-based and ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.
- The subject must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
- Has at least 1 measurable lesion on computed tomography (CT)/ magnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the investigator.
- Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.
What rules you out
- Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
- 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.
- Has received any topoisomerase inhibitor.
- Has histologically or cytologically confirmed adenosquamous carcinoma subtype or neuroendocrine features in >30% of tumor tissue.
- Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance. Subjects who received paclitaxel or docetaxel in definitive chemoradiotherapy or neoadjuvant/adjuvant treatment (chemotherapy or chemoradiotherapy) settings whose disease progressed after 6 months of treatment completion are eligible.
- 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, or other arterial thromboembolic event.
- Has a clinically significant corneal disease.
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD or ILD that cannot be ruled out by imaging at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- China
- United Kingdom
- Japan
- Korea, Republic of
- Taiwan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; United Kingdom; Japan; Korea, Republic of; Taiwan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.