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New drug targets tough esophageal cancer in early trial

NCT ID NCT07405151

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 16 times

Summary

This study tests a drug called I-DXd in 60 people with advanced esophageal cancer that has worsened after prior treatments. I-DXd is designed to attach to cancer cells and deliver a toxic payload to destroy them. The main goal is to see how many patients' tumors shrink or disappear.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ifinatamab deruxtecan (I-DXd)
What this could lead to
If it works, this could offer a new treatment option for advanced esophageal cancer that has stopped responding to other therapies.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not apply broadly. The drug may cause side effects or fail to shrink tumors in many patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oesophageal squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aichi Cancer Center ( Site 2702)

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Anhui Provincial Hospital ( Site 2506)

    RECRUITING

    Hefei, Anhui, 230071, China

  • Asan Medical Center ( Site 2901)

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Cancer Hospital ( Site 2500)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Bradfordhill ( Site 3401)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

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

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • China Medical University Hospital ( Site 3007)

    RECRUITING

    Taichung, 40447, Taiwan

  • Chulalongkorn University ( Site 3104)

    RECRUITING

    Pathumwan, Bangkok, 10330, Thailand

  • FALP ( Site 3400)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine Siriraj Hospital ( Site 3102)

    RECRUITING

    Bangkoknoi, Bangkok, 10700, Thailand

  • Henan Cancer Hospital ( Site 2501)

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hopitaux Universitaires de Geneve HUG ( Site 3701)

    RECRUITING

    Geneva, 1211, Switzerland

  • Hospital Nossa Senhora Da Conceicao ( Site 3300)

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Jinan Central Hospital ( Site 2507)

    RECRUITING

    Jinan, Shandong, 250000, China

  • Kanagawa Cancer Center ( Site 2701)

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Kantonsspital Graubünden-Medizin ( Site 3700)

    RECRUITING

    Chur, Kanton Graubünden, 7000, Switzerland

  • Liga Norte Riograndense Contra o Cancer ( Site 3301)

    RECRUITING

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • Masarykuv onkologicky ustav ( Site 4000)

    RECRUITING

    Brno, Brno-mesto, 565 53, Czechia

  • National Cancer Center ( Site 2902)

    RECRUITING

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

  • National Cancer Center Hospital ( Site 2700)

    RECRUITING

    Chūō, Tokyo, 104-0045, Japan

  • National Cheng Kung University Hospital ( Site 3001)

    RECRUITING

    Tainan, 704, Taiwan

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

    RECRUITING

    Taipei, 106, Taiwan

  • National Taiwan University Hospital ( Site 3000)

    RECRUITING

    Taipei, 100225, Taiwan

  • Oslo universitetssykehus, Radiumhospitalet ( Site 3501)

    RECRUITING

    Oslo, 0379, Norway

  • Samsung Medical Center ( Site 2900)

    RECRUITING

    Seoul, 06351, South Korea

  • Songklanagarind Hospital ( Site 3101)

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Taipei Veterans General Hospital ( Site 3005)

    RECRUITING

    Taipei, 11217, Taiwan

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

    RECRUITING

    Xiamen, Fujian, 361003, China

  • UPMC Hillman Cancer Center ( Site 3904)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Xuzhou Central Hospital ( Site 2502)

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • Zhejiang Cancer Hospital ( Site 2511)

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

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