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Monoclonal Antibodies
Codrituzumab for Solid Tumors
Phase 1
Recruiting
Led By Michael Ortiz, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis: Patients must have a diagnosis of a primary extra-cranial solid tumor that is recurrent or refractory to standard therapy.
Disease Status: Patients must have measurable disease based on RECIST 1.1.
Must not have
Patients who have received any prior GPC3-directed immunotherapy are not eligible for study entry.
Patients with uncontrolled seizures are not eligible for study entry.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing codrituzumab, a medicine that targets a specific protein on cancer cells, in children and young adults with certain types of tumors. The goal is to see if it is safe and has few side effects.
Who is the study for?
This trial is for children and young adults aged 1 to less than 22 years with solid tumors that haven't responded to treatment or have returned after treatment. They must be able to perform daily activities at least half the time, have recovered from previous treatments, not be pregnant, agree to use contraception if of reproductive age, and meet specific blood and organ function criteria.
What is being tested?
The study tests Codrituzumab's safety and effects in participants with GPC3 protein-expressing solid tumors. It examines how the body absorbs, distributes, and eliminates this drug. The goal is to find a safe dosage that causes few or mild side effects.
What are the potential side effects?
While the trial aims for minimal side effects from Codrituzumab, potential risks may include allergic reactions due to the immune system's response or other unforeseen issues related to how it affects different organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned or didn’t respond to treatment and is not in the brain.
Select...
My cancer can be measured by scans.
Select...
My blood counts and liver/kidney functions are within required ranges for treatment.
Select...
It's been over 84 days since my allogeneic transplant or over 42 days since my autologous stem cell infusion, and I don't have GvHD.
Select...
I can do most daily activities by myself.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had GPC3-directed immunotherapy.
Select...
I do not have uncontrolled seizures.
Select...
I do not have any infections that are currently uncontrolled.
Select...
I do not have anti-codrituzumab antibodies.
Select...
I do not have any brain tumors or brain damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
estimate the MTD
Secondary study objectives
response rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CodrituzumabExperimental Treatment1 Intervention
For Phase A of the study, we will use the 3+3 study design, with 2 planned dose levels, starting at 50% of the adult RP2D to confirm the pediatric RP2D/MTD. 6-9,43 Phase B will include an expansion cohort for patients with hepatoblastoma.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Monoclonal antibodies, such as codrituzumab, target specific proteins expressed on the surface of tumor cells, like GPC3, leading to direct tumor cell killing or marking them for destruction by the immune system. This targeted approach is crucial for solid tumor patients as it can minimize damage to healthy cells and reduce side effects compared to traditional chemotherapy, which non-selectively kills rapidly dividing cells.
Other common treatments include targeted therapies that inhibit specific molecules involved in tumor growth and survival, and chemotherapy, which disrupts cell division. These treatments are essential for managing solid tumors, offering options that can be tailored to the molecular characteristics of the patient's cancer.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,963 Previous Clinical Trials
597,346 Total Patients Enrolled
Chugai Pharma USAIndustry Sponsor
8 Previous Clinical Trials
4,589 Total Patients Enrolled
Michael Ortiz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken high-dose steroids or immunosuppressants for over 14 days.I had my last radiation treatment more than 14, 42, or 120 days ago, depending on the type and dose.My neurological condition has been stable for over a week without steroids, and I can use a wheelchair.My cancer has returned or didn’t respond to treatment and is not in the brain.I have never had GPC3-directed immunotherapy.I haven't taken any medication to boost my blood cells for at least a week.I am between 1 and 21 years old at the time of signing up for the study.I do not have uncontrolled seizures.I have recovered from side effects of my previous cancer treatments.I do not have any infections that are currently uncontrolled.My cancer can be measured by scans.I do not have anti-codrituzumab antibodies.My blood counts and liver/kidney functions are within required ranges for treatment.It's been over 84 days since my allogeneic transplant or over 42 days since my autologous stem cell infusion, and I don't have GvHD.My tumor shows GPC3 protein presence from any past test.I do not have any brain tumors or brain damage.I can do most daily activities by myself.
Research Study Groups:
This trial has the following groups:- Group 1: Codrituzumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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