Phase I Study of Codrituzumab for Children and Young Adults With Relapsed or Refractory Glypican 3 Positive Solid Tumors

What this Trial Is About

Researchers are studying codrituzumab to see if it is a safe treatment with few or mild side effects for children and young adults aged 1 to 21 years who have solid tumors that express the protein GPC3 and have not responded to previous treatments or have had their cancer return. The study also aims to understand how codrituzumab is processed in the body, including absorption and clearance. This is a Phase I trial sponsored by Memorial Sloan Kettering Cancer Center focusing on relapsed or refractory extra-cranial solid tumors expressing GPC3. The study has two parts Phase A uses a 33 design with two dose levels, starting at half the adult recommended dose and potentially increasing to determine the best pediatric dose. Phase B expands the study to include patients with hepatoblastoma. Participants will receive codrituzumab through weekly intravenous infusions over 21-day cycles and may continue treatment for up to 25 cycles if eligible. Dose escalation and safety will be closely monitored during the trial. Participants will be carefully evaluated before and during the study, including tumor measurements using RECIST 1.1 criteria, performance status assessments, and confirmation of GPC3 tumor expression. Researchers will estimate the maximum tolerated dose over one year and assess response rates at six weeks. Safety monitoring includes checking organ function and pregnancy status. Patients will be followed closely for side effects and treatment response throughout the study period lasting up to 25 treatment cycles.

A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment