NCT07405151RecruitingPhase 1/2
A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)
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
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 27 Mar 2026
- Primary completion date
- 12 Jun 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07405151
- EU CT number
- 2026-525213-31-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 27 Mar 2026 to the primary completion date, 12 Jun 2027
- 32 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event
- 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
Other illness
- Has clinically significant corneal disease
- 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 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.
Other
- 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 known active central nervous system metastases and/or carcinomatous meningitis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liga Norte Riograndense Contra o Cancer ( Site 3301) Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Hospital Nossa Senhora Da Conceicao ( Site 3300) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Kantonsspital Graubünden-Medizin ( Site 3700) Coordinator of this site? Confirm its status | Chur | Switzerland | Recruiting |
| Hopitaux Universitaires de Geneve HUG ( Site 3701) Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| Fundación Arturo López Pérez ( Site 3400) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Bradfordhill ( Site 3401) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Beijing Cancer Hospital ( Site 2500) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Zhejiang Cancer Hospital ( Site 2511) Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Anhui Provincial Hospital ( Site 2506) Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Jinan Central Hospital ( Site 2507) Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The First Affiliated hospital of Xiamen University ( Site 2504) Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| Xuzhou Central Hospital ( Site 2502) Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Henan Cancer Hospital ( Site 2501) Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Masarykuv onkologicky ustav ( Site 4000) Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| National Cancer Center Hospital ( Site 2700) Coordinator of this site? Confirm its status | Chūō | Japan | Recruiting |
| Aichi Cancer Center ( Site 2702) Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Kanagawa Cancer Center ( Site 2701) Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| National Cancer Center ( Site 2902) Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| Samsung Medical Center ( Site 2900) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center ( Site 2901) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Oslo universitetssykehus, Radiumhospitalet ( Site 3501) Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Faculty of Medicine Siriraj Hospital ( Site 3102) Coordinator of this site? Confirm its status | Bangkoknoi | Thailand | Recruiting |
| Songklanagarind Hospital ( Site 3101) Coordinator of this site? Confirm its status | Hat Yai | Thailand | Recruiting |
| Chulalongkorn University ( Site 3104) Coordinator of this site? Confirm its status | Pathumwan | Thailand | Recruiting |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 3003) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| China Medical University Hospital ( Site 3007) Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital ( Site 3001) Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Veterans General Hospital ( Site 3005) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital ( Site 3000) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Cancer Center (NTUCC) ( Site 3010) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital - Linkou Branch ( Site 3006) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| UPMC Hillman Cancer Center ( Site 3904) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.