Phase 1 / Phase 2: testing I-DXd for Oesophageal Squamous Cell Carcinoma
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).
Official registry: https://clinicaltrials.gov/study/NCT07405151 · Merck Sharp & Dohme LLC · enrollment listed as 60
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are I-DXd, or Rescue Medication. The registry lists allocation as na. The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC).
They plan to enroll about 60 people at 34 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F
Interventions: I-DXd, Rescue Medication
Primary outcome (registry wording): Objective Response Rate (ORR)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
Toll Free Number
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
34 listed- UPMC Hillman Cancer Center ( Site 3904) — Pittsburgh, Pennsylvania (recruiting)
+ 33 sites outside the US on the same record
FAQ about this NCT record
Is NCT07405151 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07405151?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07405151?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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