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

PHASE1RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 9, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Primary Extra-cranial Solid TumorRecurrent or Refractory Glypican 3 (GPC3)
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.

Trial Locations (5)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

30322

RECRUITING

Children's Healthcare of Atlanta (Data Collection Only), Atlanta

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

90027

RECRUITING

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

02115

RECRUITING

Dana Farber Cancer Institute (Data Collection Only), Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharma USA

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

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 | Biotech Hunter | Biotech Hunter