Actively Recruiting
A Multi-Center Phase I Study of Codrituzumab in Pediatric Patients With Relapsed or Refractory Glypican 3 (GPC3) Expressing Extra-cranial Solid Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-17
50
Participants Needed
5
Research Sites
N/A
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
Researchers are studying codrituzumab to see if it is a safe treatment with few or mild side effects for children and young adults aged 1 to 21 years who have solid tumors that express the protein GPC3 and have not responded to previous treatments or have had their cancer return. The study also aims to understand how codrituzumab is processed in the body, including absorption and clearance. This is a Phase I trial sponsored by Memorial Sloan Kettering Cancer Center focusing on relapsed or refractory extra-cranial solid tumors expressing GPC3. The study has two parts: Phase A uses a 3+3 design with two dose levels, starting at half the adult recommended dose and potentially increasing to determine the best pediatric dose. Phase B expands the study to include patients with hepatoblastoma. Participants will receive codrituzumab through weekly intravenous infusions over 21-day cycles and may continue treatment for up to 25 cycles if eligible. Dose escalation and safety will be closely monitored during the trial. Participants will be carefully evaluated before and during the study, including tumor measurements using RECIST 1.1 criteria, performance status assessments, and confirmation of GPC3 tumor expression. Researchers will estimate the maximum tolerated dose over one year and assess response rates at six weeks. Safety monitoring includes checking organ function and pregnancy status. Patients will be followed closely for side effects and treatment response throughout the study period lasting up to 25 treatment cycles.
CONDITIONS
Brief 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 study registration
- Diagnosis of primary extra-cranial solid tumor that is recurrent or refractory to standard therapy
- Positive GPC3 expression in tumor confirmed by immunohistochemistry
- Measurable disease based on RECIST 1.1 criteria
- Karnofsky or Lansky Performance Score of 50% or higher within 2 weeks of enrollment
- Stable neurologic deficits and off steroids for at least 1 week prior to study entry
- Not pregnant or breastfeeding; females must have negative pregnancy test within 7 days prior to enrollment
- Agree to use effective contraception during and for 90 days after last dose if of reproductive potential
- Fully recovered from acute toxic effects of prior therapies according to specified timeframes
- Adequate organ function as documented within 14 days of registration and 7 days of treatment start
You will not qualify if you...
- Receiving current anti-cancer therapy or investigational agents
- No tumor tissue available for GPC3 testing
- Prior GPC3-directed immunotherapy
- Uncontrolled seizures
- Systemic corticosteroids or immunosuppressive medications within 14 days prior to study entry (with exceptions)
- Documented CNS tumor, CNS metastasis, ischemia, or infarction
- Baseline QTc interval over 480 ms
- Inability to comply with follow-up or safety monitoring requirements
- Uncontrolled infection
- Prior solid organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 25 cycles of 21 days each
Participants receive weekly intravenous infusions of Codrituzumab for 21 days per cycle, with eligibility for up to 25 cycles depending on response and tolerability.
Weekly visits for treatment administration and assessments
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
J
Julia Glade Bender, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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