*LIGHTBEAM-U01 Substudy 01A in Paediatric & Young Adult Participants
Research type
Research Study
Full title
LIGHTBEAM-U01 Substudy 01A: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors UK PIP Number: MHRA-100466-PIP01-22, Decision Date: 24Mar2023 EMA PIP Number: EMEA-003257-PIP01-22, EMA Decision Number: P/0130/2023, Decision Date: 13Apr2023
IRAS ID
1008911
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for a new way to treat certain relapsed or refractory blood cancers or solid tumours. Relapsed means the cancer has come back after it had responded to previous treatment. Refractory means cancer did not respond or stopped responding to treatment.
Researchers want to learn if zilovertamab vedotin (the trial medicine) can be used to treat the cancers. Zilovertamab vedotin, is a type of targeted therapy. A targeted therapy works to control how specific types of cancer cells grow and spread.
The goal of this trial is to learn about the safety of different doses (amounts) of zilovertamab vedotin and how well people tolerate it. Researchers also want to learn how many people have cancer that responds after receiving zilovertamab vedotin.
Up to 90 children and young adults (between birth and 25 years old) with certain types of relapsed or refractory solid tumours or blood cancer will be in this trial.
Everyone in the trial will receive zilovertamab vedotin through a needle into a vein as an intravenous (IV) infusion. The treatment is given once every 3 weeks until the cancer grows, spreads, the treatment cannot be tolerated or the person leaves the trial for another reason. People may be in the trial for about 5 years.
Both the people in the trial and the researcher will know which trial treatment a person is getting. During this trial, people may give blood, urine and tumour samples, have their mouth swabbed and have physical examinations.
People may or may not benefit from the treatment received during the trial. This trial has an external group of experts that oversees the overall risk and benefit. If this group of experts decides that the trial treatment is not safe or does not show benefit, the trial can be stopped.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0001
Date of REC Opinion
22 Mar 2024
REC opinion
Further Information Favourable Opinion