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A clinical trial of ifinatamab deruxtecan in people with advanced esophageal cancer (MK-3475-06F)
EU CTIS ID: 2026-525213-31-00
What this study is testing
1. To evaluate ORR per RECIST 1.1 as assessed by BICR.
- Therapeutic exploratory (Phase II)
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
- Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
- Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC.
- Has measurable disease.
- If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy.
- Has adequate organ function.
You likely can't join if
- Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype.
- Has active infection requiring systemic therapy other than those permitted.
- 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 enrollment, severe asthma, severe chronic obstructive pulmonary disease, 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.
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
- Has clinically significant corneal disease.
- Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event.
See the full eligibility criteria
- Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
- Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC.
- Has measurable disease.
- If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy.
- Has adequate organ function.
- Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype.
- Has active infection requiring systemic therapy other than those permitted.
- 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 enrollment, severe asthma, severe chronic obstructive pulmonary disease, 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.
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
- Has clinically significant corneal disease.
- Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event.
- If infected with HIV, has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Has uncontrolled or significant cardiovascular disease.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Korea, Republic of
- Brazil
- Japan
- Switzerland
- United States
- Taiwan
- China
- Thailand
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Korea, Republic of; Brazil; Japan; Switzerland; United States and 3 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 EU CTIS; the study team decides eligibility.