Actively Recruiting
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-17
50
Participants Needed
5
Research Sites
311 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
C
Chugai Pharma USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 months up to but not including 22 years at enrollment
- Diagnosis of primary extra-cranial solid tumor that is recurrent or refractory to standard therapy
- Tumor must express GPC3 protein confirmed by immunohistochemistry
- Measurable disease based on RECIST 1.1 criteria
- Karnofsky or Lansky performance score of 50% or higher within 2 weeks before enrollment
- Neurologic deficits must be stable and off steroids for at least 1 week prior to study entry
- Not pregnant or breastfeeding; females of reproductive potential must have a negative pregnancy test within 7 days prior to enrollment
- Agreement to use effective contraception during and for 90 days after study treatment if of reproductive potential
- Fully recovered from acute effects of prior chemotherapy, immunotherapy, or radiotherapy as specified by time intervals
- Adequate organ function documented within 14 days prior to registration and within 7 days before treatment start
You will not qualify if you...
- Currently receiving anti-cancer therapy or investigational agents
- No available tumor tissue for GPC3 testing
- Prior treatment with GPC3-directed immunotherapy
- Uncontrolled seizures
- Systemic treatment with corticosteroids above 0.15 mg/kg prednisone equivalents or other immunosuppressants within 14 days prior to enrollment, except certain inhaled or topical steroids
- Documented central nervous system tumor, metastasis, ischemia, or infarction
- Baseline QTc greater than 480 ms
- Inability to comply with follow-up or safety monitoring requirements
- Uncontrolled infection
- Prior solid organ transplantation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Children's Hospital of Los Angeles (Data Collection Only)
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's Healthcare of Atlanta (Data Collection Only)
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
M
Michael Ortiz, MD
CONTACT
J
Julia Glade Bender, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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