Study of Ifinatamab Deruxtecan to Assess Safety and Effectiveness in Children With Relapsed or Refractory Solid Tumors

What this Trial Is About

Researchers are studying new treatment options for children with relapsed or refractory solid tumors, which are cancers mostly found in body organs and tissues rather than blood or fluids. The trial focuses on ifinatamab deruxtecan I-DXd, an antibody-drug conjugate designed to target proteins on cancer cells and deliver treatment directly to them. The study aims to assess the safety of I-DXd and how well children under 12 tolerate it, as well as to measure how many participants experience tumor shrinkage or disappearance. The study has two parts Part 1 evaluates safety, tolerability, and determines the recommended dose for further study, while Part 2 expands to assess effectiveness. Participants receive ifinatamab deruxtecan through an intravenous infusion on day 1 of each 3-week treatment cycle. Treatment continues until the cancer progresses or the participant stops treatment. The trial includes children from 1 month up to 18 years old with specific types of relapsed or refractory tumors. Participants will undergo regular assessments including monitoring for side effects and treatment response over up to approximately 5 years. Researchers will collect data on dose-limiting toxicities, adverse events, and tumor responses, as well as blood samples to study drug levels and immune responses. The primary outcomes focus on safety and tumor control, while secondary measures include duration of response, progression-free survival, and overall survival. The long-term follow-up will help understand the treatments impact over time.

A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)