NCT04928677

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

A Multi-Center Phase I Study of Codrituzumab in Pediatric Patients With Relapsed or Refractory Glypican 3 (GPC3) Expressing Extra-cranial Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to find out whether codrituzumab is a safe treatment that causes few or mild side effects in children and young adults who have solid tumors that express the protein GPC3. The researchers also want to study the way codrituzumab is absorbed, distributed, and cleared from the body.

Conditions

• Primary Extra-cranial Solid Tumor
• Recurrent or Refractory Glypican 3 (GPC3)

Interventions

Type	Name	Description
DRUG	Codrituzumab	For Phase A (Dose Escalation), the starting dose (dose level 1) will be 10 mg/kg with 1 planned dose escalation to 20 mg/kg (dose level 2) if dose level 1 is determined to be safe and tolerable. Once a RP2D/MTD is identified in Phase A, then Phase B (hepatoblastoma expansion cohort) will open and allow for enrollment of up to 10 additional patients.For both phases, patients will receive codrituzumab IV once per week for a period of 21 days per cycle. Patients will be eligible for up to 25 cycles.

Timeline

• Start date: 2021-06-09
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2021-06-16
• Last updated: 2026-02-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study