Ifinatamab Deruxtecan in kids with relapsed or refractory solid cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part pediatric trial testing the antibody-drug conjugate I-DXd (MK-2400) in relapsed or refractory solid tumors. Part 1 focuses on safety, tolerability, and finding a recommended dose for expansion. Part 2 expands to evaluate how well the drug works in osteosarcoma, neuroblastoma, rhabdomyosarcoma, or Wilms tumor, with eligibility limited to children under 18. Participants must have radiologically proven disease progression after prior therapy and no satisfactory alternatives, with specific age ranges for each part. The study is conducted at three U.S. sites and is sponsored by Merck with Daiichi Sankyo as collaborator.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Los Angeles ( Site 4006)
  Los Angeles, California, United States Recruiting
• Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
  Aurora, Colorado, United States Recruiting
• Johns Hopkins All Children's Hospital ( Site 4025)
  St. Petersburg, Florida, United States Recruiting
• University of Iowa Hospitals ( Site 4017)
  Iowa City, Iowa, United States Recruiting
• Dana Farber Cancer Center ( Site 4013)
  Boston, Massachusetts, United States Recruiting
• Corewell Health ( Site 4001)
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.