Ifinatamab Deruxtecan for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment called ifinatamab deruxtecan, designed for children whose solid tumors have returned or resisted previous treatments. The goal is to determine if this treatment can shrink or eliminate the cancer and whether young children can tolerate it safely. Suitable candidates are those under 12 years old with a solid tumor that has worsened after prior treatments and who lack other viable treatment options. As a Phase 1 and Phase 2 trial, the research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group of patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that ifinatamab deruxtecan is likely to be safe for humans?
Research has shown that ifinatamab deruxtecan, the treatment under study, is generally well-tolerated by patients. In studies involving individuals with small cell lung cancer, 36.5% of participants experienced serious side effects related to the treatment. Common side effects included nausea, low white blood cell levels (neutropenia), and low red blood cell levels (anemia). However, these side effects were considered manageable. Overall, the safety profile of ifinatamab deruxtecan resembles that of similar treatments, suggesting it is safe for many patients.12345
Why do researchers think this study treatment might be promising?
Ifinatamab Deruxtecan is unique because it combines an antibody with a chemotherapy drug, specifically targeting and attacking cancer cells. Unlike standard treatments like chemotherapy, which can affect both healthy and cancerous cells, Ifinatamab Deruxtecan is designed to precisely deliver its toxic payload to cancer cells, potentially reducing side effects. Researchers are excited about this treatment because its targeted approach could improve effectiveness and safety, offering new hope for patients with difficult-to-treat cancers.
What evidence suggests that ifinatamab deruxtecan might be an effective treatment for relapsed or refractory solid tumors?
Research has shown that ifinatamab deruxtecan (I-DXd) may effectively treat certain cancers. In a study with patients who had previously treated small cell lung cancer, I-DXd significantly shrank tumors in nearly half of the patients. The treatment also prevented cancer from worsening for an average of 4.9 months and extended patients' lives for an average of 10.3 months after starting treatment. These results suggest that I-DXd might also benefit other hard-to-treat cancers, such as relapsed or stubborn solid tumors in children. Participants in this trial will receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression.12567
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for children and teens (from 1 month up to under 18 years old) with solid tumors that have come back or didn't respond to treatment, including certain cancers like osteosarcoma, neuroblastoma, rhabdomyosarcoma, or Wilms tumor. Participants must have tried at least one prior therapy and not have better standard options.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
Dose Evaluation
Evaluate the safety and tolerability and determine the recommended dose for expansion (RDE) of I-DXd
Efficacy Expansion
Participants continue to receive treatment to assess efficacy and disease control
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ifinatamab Deruxtecan
Trial Overview
The study is testing a new drug called Ifinatamab Deruxtecan (I-DXd), which targets cancer cells directly using an antibody linked to chemotherapy. The main goals are to see if it's safe in young patients and whether it helps shrink their tumors.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Daiichi Sankyo
Industry Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Citations
Ifinatamab Deruxtecan Demonstrated Clinically Meaningful ...
September 7, 2025 10:45 am EDT. An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated ...
Primary Analysis of the Phase II IDeate-Lung01 Trial
Despite this, I-DXd 12 mg/kg demonstrated an ORR of 48.2%, median DOR of 5.3 months, median PFS of 4.9 months, and median OS of 10.3 months.
3.
ascopost.com
ascopost.com/news/september-2025/previously-treated-es-sclc-i-dxd-demonstrates-high-response-rate/Previously Treated ES-SCLC: I-DXd Demonstrates High ...
Median progression-free survival was 4.9 months, and median overall survival was 10.3 months. Clinical benefit was observed regardless of ...
Primary Analysis of the Phase II IDeate-Lung01 Trial - PubMed
I-DXd 12 mg/kg once every 3 weeks showed promising efficacy in patients with previously treated ES-SCLC. Overall, 183 patients received I-DXd: ...
Ifinatamab Deruxtecan Granted Priority Review in ...
The dose expansion part of the SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate.4,5
Ifinatamab Deruxtecan Granted Breakthrough Therapy ...
Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer.
NCT05280470 | Ifinatamab Deruxtecan (I-DXd) in Subjects ...
This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) ...
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