LIGHTBEAM-U01, Substudy 01D

A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (LIGHTBEAM-U01, Substudy 01D)

Agent: Ifinatamab deruxtecan (I-DXd; MK-2400)
Phase Ib/II
Status Recruiting
Sponsor Merck Sharp & Dohme LLC

 

For further information please also consult https://clinicaltrials.gov/study/NCT07630974.

LIGHTBEAM-U01 Substudy 01D is a phase 1b/2 study of ifinatamab deruxtecan (I-DXd) in children and adolescents whose solid tumors have returned after treatment or have not responded to treatment. It examines safety, tolerability and whether tumors shrink during treatment.

Ifinatamab deruxtecan (also called I-DXd or MK-2400) is an antibody–drug conjugate (ADC). It combines an antibody that recognizes a protein on cancer cells with an anticancer medicine. This approach aims to deliver treatment to cancer cells. Its safety and effectiveness in children are still being studied.

WHO is the trial for?
  • Children and adolescents with solid tumors that have returned (relapsed) or have not responded to treatment (refractory).
  • Part 1: ages 1 month to under 12 years, with eligible solid tumors outside the brain or spinal cord.
  • Part 2: ages 1 month to under 18 years, with osteosarcoma, neuroblastoma, rhabdomyosarcoma or Wilms tumor.
  • The cancer must have progressed after at least one prior treatment for locally advanced or metastatic disease, and there must be no satisfactory standard treatment option.

Important exclusions include certain lung conditions (such as interstitial lung disease/pneumonitis), significant heart disease, active infection and some other medical conditions.
The study team checks all criteria.

WHAT is the key question that this trial is attempting to answer?

 Is ifinatamab deruxtecan safe and tolerable for children with relapsed or refractory solid tumors, particularly those younger than 12? How many participants have tumors that shrink or disappear during treatment?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 This trial is currently conducted in the United States, Australia, Belgium, Czechia, Denmark, France, Hungary, Israel, Netherlands, Slovakia, South Korea, Spain, Sweden.

Please check the registry for the latest participating hospitals and their recruitment status.

Central study contact:
Email: Trialsites@msd.com
Phone: +1 888 577 8839

STUDY DESIGN: What does the study look like?

 Phase 1b/2 interventional study with approximately 134 participants planned.

Part 1 evaluates safety and how well younger children tolerate I-DXd. Part 2 studies the treatment in children and adolescents with selected tumor types and measures tumor response.

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

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken