A clinical trial of ifinatamab deruxtecan in people with advanced esophageal cancer (MK-3475-06F)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

21 May 2026 → ongoing

Decision date (initial)

2026-05-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Daiichi Sankyo · Merck Sharp & Dohme LLC

External identifiers

EU CT number

2026-525213-31-00

WHO UTN

U1111-1329-6558

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacokinetic, Efficacy

1. To evaluate ORR per RECIST 1.1 as assessed by BICR.

Secondary objectives 4

1. To evaluate the DOR as assessed by BICR per RECIST 1.1.
2. To evaluate PFS as assessed by BICR per RECIST 1.1.
3. To evaluate OS.
4. To evaluate I-DXd safety and tolerability.

Conditions and MedDRA coding

Esophageal squamous cell carcinoma

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 11

1. Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype.
2. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
3. Has clinically significant corneal disease.
4. Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event.
5. If infected with HIV, has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
6. Has uncontrolled or significant cardiovascular disease.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
8. Has known active central nervous system metastases and/or carcinomatous meningitis.
9. 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
10. Has active infection requiring systemic therapy other than those permitted.
11. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR)

Secondary endpoints 5

1. Duration of response (DOR)
2. Progression-free survival (PFS)
3. Overall survival (OS)
4. Number of participants who experience an adverse event (AE)
5. Number of participants who discontinue study intervention due to an AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Yanfang Liu

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Yanfang Liu

Third parties 5

Locations

4 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 37 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications