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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether codrituzumab is safe and has few side effects in children and young adults with solid tumors that express the protein GPC3.

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.Check my eligibility
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.See study design
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 below
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My cancer has returned or didn’t respond to treatment and is not in the brain.
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My cancer can be measured by scans.
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My blood counts and liver/kidney functions are within required ranges for treatment.
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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.
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I can do most daily activities by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
estimate the MTD
Secondary outcome measures
response rate

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,929 Previous Clinical Trials
597,168 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

Codrituzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04928677 — Phase 1
Solid Tumors Research Study Groups: Codrituzumab
Solid Tumors Clinical Trial 2023: Codrituzumab Highlights & Side Effects. Trial Name: NCT04928677 — Phase 1
Codrituzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04928677 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 or more being enlisted for this investigation?

"The study requires potential participants to be aged between 1 year old and 21 years. Noteworthy, there are 301 trials that cater to minors while 2194 studies have been designed with seniors in mind."

Answered by AI

What is the aggregate population size of individuals participating in this investigation?

"This clinical trial necessitates 50 enrollees that meet the predetermined requirements. Those eligible can take part at either Cincinnati Children's Hospital Medical Center in Ohio or Memorial Sloan Kettering Cancer Centre located in New york City."

Answered by AI

What other research initiatives have been conducted surrounding Codrituzumab?

"Currently, there is just one clinical trial of codrituzumab. It has yet to reach Phase 3 and the primary study site is Los Angeles, California although it is also running trials in three other locations."

Answered by AI

Who meets the eligibility criteria for participation in this investigation?

"This clinical trial is looking to recruit 50 participants between 1 year and 21 years of age with cancer. To be eligible, the patient must meet certain criteria including being at least 12 months old but younger than 22 on enrollment date; having a diagnosis of relapsed or refractory hepatoblastoma; achieving Karnofsky Performance Score (for patients > 16) or Lansky Performance Score (for patients ≤16) greater than 50% within 2 weeks from enrollment; any tumor that has recurred twice is considered relapsed and any tumor which progresses despite maximal standard therapies is classified as refractory, plus disease must be measurable according to REC"

Answered by AI

Is this program the first of its kind to be conducted?

"Presently, Chugai Pharma USA's drug Codrituzumab has a single live trial being conducted over 3 cities in 1 state. In 2021 the first clinical tests were completed and Phase 1 approval was obtained with 50 patients participating. Since then two further experiments have been carried out."

Answered by AI

Is this investigation currently accepting enrollees?

"Affirmative, clinicaltrials.gov indicates that this medical investigation is recruiting participants. It was initially announced on June 9th 2021 and amended most recently on October 28th 2022. 50 individuals are required from 3 distinct sites for the study to be successful."

Answered by AI

What potential risks could a patient face if they were to be treated with Codrituzumab?

"The limited data that exists suggests Codrituzumab is relatively safe, so it receives a score of 1."

Answered by AI
~15 spots leftby Jun 2025