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

NCT07405151 | Recruiting Phase 1 FDA Drug

• 5 other identifiers: 3475-06F2026-525213-31-00U1111-1329-6558MK-3475-06FjRCT2041250179
• Study Type: interventional
• Target: 60
• Locations: 7 countries
• Sites: 18

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.

Conditions

Oesophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

  Up to approximately 14 months

Secondary Outcomes (5)

• Duration of Response (DOR)

  Up to approximately 18 months

• Progression-Free Survival (PFS)

  Up to approximately 18 months

• Overall Survival (OS)

  Up to approximately 26 months

• Number of Participants Who Experience an Adverse Events (AEs)

  Up to approximately 18 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 18 months

Study Arms (1)

I-DXd

EXPERIMENTAL

Participants will be administered I-DXd every 3 weeks until progressive disease or discontinuation criteria are met.

Biological: I-DXd; Drug: Rescue Medication

Interventions

I-DXd BIOLOGICAL

IV Infusion

Also known as: Ifinatamab Deruxtecan, DS-7300a, MK-2400

I-DXd

Rescue Medication DRUG

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

I-DXd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: collaborator
• Merck Sharp & Dohme LLC: lead

Study Sites (18)

Beijing Cancer Hospital ( Site 2500)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Masarykuv onkologicky ustav ( Site 4000)

Brno, Brno-mesto, 565 53, Czechia

RECRUITING

Aichi Cancer Center ( Site 2702)

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

Kanagawa Cancer Center ( Site 2701)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

National Cancer Center Hospital ( Site 2700)

Chūō, Tokyo, 104-0045, Japan

RECRUITING

Oslo universitetssykehus, Radiumhospitalet ( Site 3501)

Oslo, 0379, Norway

RECRUITING

National Cancer Center ( Site 2902)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

Asan Medical Center ( Site 2901)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 2900)

Seoul, 06351, South Korea

RECRUITING

Kantonsspital Graubünden-Medizin ( Site 3700)

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

Hopitaux Universitaires de Geneve HUG ( Site 3701)

Geneva, 1211, Switzerland

RECRUITING

Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)

Kaohsiung City, 83301, Taiwan

RECRUITING

China Medical University Hospital ( Site 3007)

Taichung, 40447, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 3001)

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 3000)

Taipei, 10002, Taiwan

RECRUITING

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

Taipei, 106, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 3005)

Taipei, 11217, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)

Taoyuan, 33305, Taiwan

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): June 12, 2027
• Study Completion (Estimated): June 12, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (3); TW (7); CH (2); JP (3); CZ (1); NO (1); CN (1)