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RECRUITING
NCT04928677
PHASE1

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

1 Year - 21 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-06-09

Completion Date

2027-06

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

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.

Locations (5)

Children's Hospital of Los Angeles (Data Collection Only)

Los Angeles, California, United States

Children's Healthcare of Atlanta (Data Collection Only)

Atlanta, Georgia, United States

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States