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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 (Jun 2026). This Phase 1 trial studies Codrituzumab for primary extra-cranial solid tumor.

Phase 1RecruitingMemorial Sloan Kettering Cancer CenterNCT04928677Data as of Jun 2026

Treatment: CodrituzumabThe 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.

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Extracted eligibility criteria

Treatments studied

Other

Codrituzumab

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.

Demographics

Ages 1–21

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 →

Frequently asked questions

Is NCT04928677 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior gpc3-directed immunotherapy disqualifies patients from enrollment.

Does this trial require GPC3?

Yes, GPC3 expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 21 years or younger and at least 1 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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