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Oesophageal Squamous Cell CarcinomaPhase 1/2NCT07405151

A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)

A Phase 1/2 study testing I-DXd and Rescue Medication in people with Oesophageal Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 32 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oesophageal Squamous Cell Carcinoma
What is being tested?
I-DXd and Rescue Medication
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
32 sitesin 11 countries
Study dates
27 Mar 2026to 12 Jun 2028
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

32 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

32 sites in 11 countries

China7 sites, 7 recruiting

  • Beijing Cancer Hospital ( Site 2500)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, +8601088140650

    Recruiting

  • Zhejiang Cancer Hospital ( Site 2511)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, +8660571-88122261

    Recruiting

  • Anhui Provincial Hospital ( Site 2506)

    Hefei, Anhui, 230071

    Study Coordinator, +86055162283760

    Recruiting

  • Jinan Central Hospital ( Site 2507)

    Jinan, Shandong, 250000

    Study Coordinator, +86053168623107

    Recruiting

  • The First Affiliated hospital of Xiamen University ( Site 2504)

    Xiamen, Fujian, 361003

    Study Coordinator, +865922139767

    Recruiting

  • Xuzhou Central Hospital ( Site 2502)

    Xuzhou, Jiangsu, 221000

    Study Coordinator, +8651680812397

    Recruiting

  • Henan Cancer Hospital ( Site 2501)

    Zhengzhou, Henan, 450008

    Study Coordinator, +864000371818

    Recruiting

Other trials in China

Taiwan7 sites, 7 recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)

    Kaohsiung City, 83301

    Study Coordinator, +88677317123

    Recruiting

  • China Medical University Hospital ( Site 3007)

    Taichung, 40447

    Study Coordinator, 886-4-22052121

    Recruiting

  • National Cheng Kung University Hospital ( Site 3001)

    Tainan, 704

    Study Coordinator, +886-6-235-3535

    Recruiting

  • National Taiwan University Hospital ( Site 3000)

    Taipei, 100225

    Study Coordinator, +886-2-23123456

    Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 3010)

    Taipei, 106

    Study Coordinator, +886223220322

    Recruiting

  • Taipei Veterans General Hospital ( Site 3005)

    Taipei, 11217

    Study Coordinator, 886-2-28717270

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)

    Taoyuan, 33305

    Study Coordinator, +88633281200

    Recruiting

Other trials in Taiwan

Japan3 sites, 3 recruiting

  • National Cancer Center Hospital ( Site 2700)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • Aichi Cancer Center ( Site 2702)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Kanagawa Cancer Center ( Site 2701)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

South Korea3 sites, 3 recruiting

  • National Cancer Center ( Site 2902)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +8219200440

    Recruiting

  • Asan Medical Center ( Site 2901)

    Seoul, 05505

    Study Coordinator, +82230101120

    Recruiting

  • Samsung Medical Center ( Site 2900)

    Seoul, 06351

    Study Coordinator, +82234101796

    Recruiting

Other trials in South Korea

Thailand3 sites, 3 recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 3102)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624194488

    Recruiting

  • Songklanagarind Hospital ( Site 3101)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Chulalongkorn University ( Site 3104)

    Pathumwan, Bangkok, 10330

    Study Coordinator, 02-256-4533

    Recruiting

Other trials in Thailand

Brazil2 sites, 2 recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 3301)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +55 84 4009-5595

    Recruiting

  • Hospital Nossa Senhora Da Conceicao ( Site 3300)

    Porto Alegre, Rio Grande do Sul, 91350-200

    Study Coordinator, +555135160954

    Recruiting

Other trials in Brazil

Chile2 sites, 2 recruiting

  • Fundación Arturo López Pérez ( Site 3400)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224457398

    Recruiting

  • Bradfordhill ( Site 3401)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

Other trials in Chile

Switzerland2 sites, 2 recruiting

  • Kantonsspital Graubünden-Medizin ( Site 3700)

    Chur, Kanton Graubünden, 7000

    Study Coordinator, +41 81 256 61 11

    Recruiting

  • Hopitaux Universitaires de Geneve HUG ( Site 3701)

    Geneva, 1211

    Study Coordinator, +41 22 372 29 01

    Recruiting

Other trials in Switzerland

United States1 site, 1 recruiting

  • UPMC Hillman Cancer Center ( Site 3904)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 816-898-9413

    Recruiting

Other trials in United States

Czechia1 site, 1 recruiting

  • Masarykuv onkologicky ustav ( Site 4000)

    Brno, Brno-mesto, 565 53

    Study Coordinator, +420543131111

    Recruiting

Other trials in Czechia

Norway1 site, 1 recruiting

  • Oslo universitetssykehus, Radiumhospitalet ( Site 3501)

    Oslo, 0379

    Study Coordinator, +4722934000

    Recruiting

Other trials in Norway

About this study

Official title: 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

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.

Read the detailed description

The master screening protocol is MK-3475-U06 (KEYMAKER-U06)

Being tested
I-DXd, Rescue Medication
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-DXdBiological

    Also called Ifinatamab Deruxtecan, DS-7300a, MK-2400

    IV Infusion

  • Rescue MedicationDrug

    Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label

Study groups in NCT07405151
Study groupRoleWhat they receive
I-DXdExperimentalParticipants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met.
Receives: Biological: I-DXd; Drug: Rescue Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 14 months

Secondary outcomes (5)

  1. Duration of Response (DOR)

    For participants who demonstrate a confirmed CR (disappearance of all target lesions) or (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 18 months

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 18 months

  3. Overall Survival (OS)

    OS is defined as time from randomization to death due to any cause.

    Measured: Up to approximately 26 months

  4. Number of Participants Who Experience an Adverse Events (AEs)

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 18 months

  5. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start27 Mar 2026
  3. Primary completion12 Jun 2027 (estimated)
  4. Study completion12 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07405151
Sponsor's protocol ID
3475-06F
Other IDs
2026-525213-31-00, U1111-1329-6558, MK-3475-06F, jRCT2041250179
Status last verified
Sep 2026
First submitted
5 Feb 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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