OncoMatch/Clinical Trials/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
Is NCT04928677 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Codrituzumab for primary extra-cranial solid tumor.
Treatment: Codrituzumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: GPC3 expression (IHC 1+ or higher)
Patients must have demonstrated a minimum of 1+ GPC3 expression via immunohistochemistry (IHC) on any prior tumor sample. This GPC3 expression via IHC will be centrally confirmed by Ventana.
Prior therapy
Cannot have received: gpc3-directed immunotherapy
Lab requirements
Blood counts
Hgb > 8 gm/dL (may be transfusion-supported); Platelet count > 50,000/mm^3 (transfusion independent); ANC > 1000/mm^3; INR ≤ 2.5
Kidney function
GFR ≥ 50 mL/min/1.73 m^2 as measured using urine creatinine clearance, serum cystatin c, radioisotope GFR, or serum creatinine as measured by the Schwartz equation
Liver function
Total Bilirubin (sum of conjugated + unconjugated) ≤ 3x institutional ULN for age; AST ≤ 5x institutional ULN for age; ALT ≤ 5x institutional ULN for age; Serum albumin ≥ 2 g/dL
Cardiac function
QTc ≤ 480 ms (Bazett formula)
Hgb > 8 gm/dL (may be transfusion-supported); Platelet count > 50,000/mm^3 (transfusion independent); Absolute neutrophil count (ANC) > 1000/mm^3; INR ≤ 2.5; Total Bilirubin (sum of conjugated + unconjugated) ≤ 3 times institutional upper limit of normal (ULN) for age; Aspartate aminotransferase (AST) ≤ 5 times institutional ULN for age; Alanine Aminotransferase (ALT) ≤ 5 times institutional ULN for age; Serum albumin ≥ 2 g/dL; GFR ≥ 50 mL/min/1.73 m^2; QTc ≤ 480 ms (Bazett formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Los Angeles (Data Collection Only) · Los Angeles, California
- Children's Healthcare of Atlanta (Data Collection Only) · Atlanta, Georgia
- Dana Farber Cancer Institute (Data Collection Only) · Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center · New York, New York
- Cincinnati Children's Hospital Medical Center · Cincinnati, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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