Clinical trial 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 IV infusion (through 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
- The study aims to find out how effective and safe ifinatamab deruxtecan is compared with usual chemotherapy for this cancer.
- Who it's for
- Adults with unresectable advanced or metastatic esophageal squamous cell carcinoma who have progressed after platinum‑based therapy and an immune checkpoint inhibitor.
- What's involved
- Participants will be randomly assigned to receive either ifinatamab deruxtecan or the investigator’s choice of chemotherapy, with regular clinic visits for treatment administration and safety tests.
- Time commitment
- The trial continues until disease progression or unacceptable side effects, with periodic visits and assessments over several months.
- 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 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...
- Has at least 1 measurable lesion on computed tomography (CT)/magnetic resonance imaging (MRI) according to RECIST v1.1 as assessed by the...
You likely can't join if
- 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...
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring...
See the full eligibility criteria
- 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.
- 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 is enrolling
- Phoenix, Arizona, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- Morristown, New Jersey, United States
- Brooklyn, New York, United States
- Hershey, Pennsylvania, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Fort Worth, Texas, United States
- Fairfax, Virginia, United States
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Anyang, China
+ 121 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, but 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?
This study is enrolling now at Phoenix, Arizona, United States; Fullerton, California, United States; Los Angeles, California, United States; Orange, California, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States and 135 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.