LIGHTBEAM-U01, Substudy 01A

Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (e.g. Ewing Sarcoma) (LIGHTBEAM-U01, Substudy 01A)

Agent: Zilovertamab vedotin
Phase I/II
Status Recruiting
Sponsor Merck Sharp & Dohme LLC

 

For further information please also consult https://clinicaltrials.gov/study/NCT06395103.

LIGHTBEAM-U01 Substudy 01A is a Phase 1/2 study looking at the safety and potential benefits of zilovertamab vedotin for children and young adults whose cancer has returned after treatment or has not responded to treatment. It includes certain blood cancers, neuroblastoma and Ewing sarcoma.

Zilovertamab vedotin is an antibody–drug conjugate (ADC). It combines an antibody designed to recognize a target on cancer cells with an attached cancer-fighting medicine. Researchers are studying whether it can help control these cancers and what side effects it may cause.

WHO is the trial for?
  • Children and young adults with certain cancers that have come back (relapsed) or have not responded to treatment (refractory).
  • For solid tumors: neuroblastoma or Ewing sarcoma.
  • The study accepts participants aged 6 months to 25 years; age requirements may differ by cancer type.

    Important exclusions include some serious heart or liver conditions, active infections, certain recent cancer treatments, and ongoing significant nerve problems. The study team will assess full eligibility.

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

 Is zilovertamab vedotin safe and tolerable for children and young adults with these cancers? What dose is appropriate, and does treatment show signs of helping to control the disease?

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 US, Australia, Belgium., Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey, and the United Kingdom.

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

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

STUDY DESIGN: What does the study look like?

 Phase 1/2 study of zilovertamab vedotin. In the early part, researchers assess safety, side effects and an appropriate dose. The study also looks for early signs of efficacy.

Participants receive escalating doses of zilovertamab vedotin via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).

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