IFINATAMAB DERUXTECAN for Esophageal squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).\n- Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC.\n- Has measurable disease.\n- If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy.\n- Has adequate organ function."}

Exclusion criteria

• {"criterion_text":"- Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype.\n- Has active infection requiring systemic therapy other than those permitted.\n- 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.\n- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.\n- Has clinically significant corneal disease.\n- Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event.\n- If infected with HIV, has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.\n- Has uncontrolled or significant cardiovascular disease.\n- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n- Has known active central nervous system metastases and/or carcinomatous meningitis.\n- 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"}

Primary endpoints

• {"endpoint_text":"- Objective response rate (ORR)","definition_or_measurement_approach":"To evaluate ORR per RECIST 1.1 as assessed by BICR."}

Secondary endpoints

• {"endpoint_text":"- Duration of response (DOR)","definition_or_measurement_approach":"As assessed by BICR per RECIST 1.1."}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":"As assessed by BICR per RECIST 1.1."}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of participants who experience an adverse event (AE)","definition_or_measurement_approach":"Count of participants experiencing one or more AEs."}
• {"endpoint_text":"- Number of participants who discontinue study intervention due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study intervention because of an AE."}

Czechia

Earliest CTIS Part Ii Submission Date

28-04-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

14

Number Of Sites

1

Number Of Participants

3

France

Earliest CTIS Part Ii Submission Date

25-02-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

76

Number Of Sites

3

Number Of Participants

3

Germany

Earliest CTIS Part Ii Submission Date

24-04-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

18

Number Of Sites

2

Number Of Participants

4

Norway

Earliest CTIS Part Ii Submission Date

16-04-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

26

Number Of Sites

1

Number Of Participants

2

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Almac Clinical Services LLC

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

Bioclinica Inc.

Name

PPD Global Central Labs

Name

Icon Clinical Research Limited

Responsibilities

VoE and VOP Assessments for the study and central imaging vendor through life of study

Third parties

• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"VoE and VOP Assessments for the study and central imaging vendor through life of study","organisation_type":"Pharmaceutical company"}