BridgeMD
New treatment option for Esophageal Squamous Cell Carcinoma
Official title A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
ClinicalTrials.gov ID: NCT06644781
What this study is testing
What is Ifinatamab deruxtecan?
Ifinatamab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Also referred to as I-DXd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the...
You likely can't join if
- 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...
See the full eligibility 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...
- Has an ECOG PS of 0 or 1 within 7 days prior to Cycle 1 Day 1.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
- Detroit, Michigan, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Fort Worth, Texas, United States
- Fairfax, Virginia, United States
- Brussels, Belgium
- Edegem, Belgium
- Leuven, Belgium
- Anyang, China
- Beijing, China
- Changchun, China
- Changzhou, China
- Chengdu, China
- Fuzhou, China
- Harbin, China
- Hefei, China
- Jinan, China
- Jining, China
- Nanning, China
+ 59 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fullerton, California, United States; Detroit, Michigan, United States; Memphis, Tennessee, United States; Nashville, Tennessee, United States; Fort Worth, Texas, United States; Fairfax, Virginia, United States and 73 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.