Recruiting
Phase 1
Phase 2

I-DXd

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07630974

Conditions

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Ifinatamab Deruxtecan

Study Details

Brief summary:

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors:

  • Relapsed means the cancer came back after treatment
  • Refractory means the cancer did not respond (get smaller or go away) to treatment
  • Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids

The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:

  • About the safety of I-DXd and if children younger than 12 years old tolerate it
  • How many children who receive I-DXd have the cancer get smaller or go away

Conditions

Malignant Neoplasm

Study ID

NCT07630974

Start date

Jul 6, 2026

Status verified date

Sep, 2026

Completion date

Aug 17, 2031

Anticipated

Primary completion date

Aug 17, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

The main inclusion criteria include but are not limited to the following:

  • In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens).
  • Is an individual of any sex/gender, ≥1 month to <12 years of age for Part 1 and ≥1 month to <18 years for Part 2 at the time of providing the informed consent or assent, as applicable
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

The main exclusion criteria include but are not limited to the following:

  • Has clinically significant corneal disease
  • Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
  • Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
  • 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, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
  • Has an active, known or suspected autoimmune disease.
  • Has history of solid organ transplant.
  • Has history of allogeneic stem cell transplant (SCT).
  • Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
  • Has active infection requiring systemic therapy
  • Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Study Design

Enrollment

134 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ifinatamab Deruxtecan

Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression

Interventions

Ifinatamab Deruxtecan

IV infusion

Primary outcome measure

  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT) [ Time Frame: Cycle 1 (up to approximately 21 days); each cycle is 21 days ]
  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]
  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 5 years ]
  • Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs [ Time Frame: Up to approximately 5 years ]
  • Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT) [ Time Frame: Up to approximately 5 years ]
  • Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST) [ Time Frame: Up to 4 Months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-777-6740

University of Iowa Hospitals ( Site 4017)

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Study Coordinator

319-356-2296

Dana Farber Cancer Center ( Site 4013)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-632-4580

Rutgers Cancer Institute of New Jersey ( Site 4008)

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Study Coordinator

732-235-2465

Memorial Sloan Kettering Cancer Center ( Site 4010)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

888-492-8401

New York Medical College ( Site 4023)

Recruiting

Valhalla, New York, United States, 10595

Contacts

Study Coordinator

914-614-4270

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Study Coordinator

701-234-2000

Children's Hospital of Philadelphia (CHOP) ( Site 4021)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

267-425-5544

Sanford Children's Hospital ( Site 4015)

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

605-312-1000

University of Texas M.D. Anderson Cancer Center ( Site 4007)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-792-5410

Intermountain - Primary Children's Hospital ( Site 4014)

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Study Coordinator

801-662-4700

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.