NCT07405151 A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)
| NCT ID | NCT07405151 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Oesophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2027-06-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-03-27 with a primary completion date of 2027-06-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype * 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 * 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07405151 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oesophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07405151 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07405151 currently recruiting?
Yes, NCT07405151 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07405151 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Natal, Brazil, Porto Alegre, Brazil, Santiago, Chile and 11 additional locations.
Who is sponsoring the NCT07405151 clinical trial?
NCT07405151 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 60 participants.