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A clinical trial of ifinatamab deruxtecan in people under age 18 who have certain types of cancer (MK-9999-01D)
EU CTIS ID: 2025-522339-32-00
What this study is testing
1. Part 1: To evaluate the safety and tolerability and to determine the RDE of ifinatamab deruxtecan (I-DXd) in pediatric participants aged ≥1 month to <12 years with relapsed, refractory solid tumors (excluding primary CNS) 2. Part 1 and Part 2: To evaluate the preliminary antitumor effect of I-DXd in terms of ORR (NBL, RMS, or WT) and DCS-4 (OST) in participants with NBL, RMS, WT, or OST per investigator assessment by tumor type
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. Participants with ≤Grade 2 alopecia are also eligible
You likely can't join if
- Clinically significant corneal disease
- History of human immunodeficiency virus (HIV) infection
- Known additional malignancy that is progressing or has required active treatment within the past 1 year
- 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
See the full eligibility criteria
- 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. Participants with ≤Grade 2 alopecia are also eligible
- Clinically significant corneal disease
- History of human immunodeficiency virus (HIV) infection
- Known additional malignancy that is progressing or has required active treatment within the past 1 year
- 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
- History of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
- Uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
- History of ILD/pneumonitis (including drug-induced ILD/pneumonitis), current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
- Has an active, known or suspected autoimmune disease
- History of solid organ transplant
- History of allogeneic stem cell transplant (SCT)
- 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, (ie, without evidence of progression) for at least 4 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Taiwan
- Canada
- United States
- Chile
- Korea, Republic of
- Turkey
- Colombia
- Brazil
- United Kingdom
- Israel
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Taiwan; Canada; United States; Chile; Korea, Republic of and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.