134 Participants NeededMy employer runs this trial

Ifinatamab Deruxtecan for Cancer

Recruiting at 25 trial locations
TF
Overseen ByToll Free Number
Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

MD

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

I have recovered from side effects of past cancer treatments.
My hormone-related side effects are controlled or my nerve symptoms are mild.
My cancer has come back or did not respond to treatment and is not a primary brain tumor.
See 2 more

Exclusion Criteria

I do not have active or untreated brain or spinal cancer involvement.
I have an active or suspected autoimmune disease.
I am still recovering from major surgery or have ongoing surgical complications.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

21 days per cycle
1 visit per cycle (in-person)

Dose Evaluation

Evaluate the safety and tolerability and determine the recommended dose for expansion (RDE) of I-DXd

Up to 4 months

Efficacy Expansion

Participants continue to receive treatment to assess efficacy and disease control

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Ifinatamab DeruxtecanExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

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.

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41086386/

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) ...