What side effects are associated with this type of intervention?

Common treatments for solid tumors, including monoclonal antibodies like codrituzumab, often cause side effects such as infusion reactions (fever, chills, rash), fatigue, nausea, and liver toxicity. Chemotherapy can lead to hematologic toxicity (neutropenia, anemia), gastrointestinal issues (nausea, vomiting, diarrhea), and neurotoxicity. Targeted therapies may also result in specific organ toxicities depending on their mechanism of action.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of solid tumors. For instance, pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, have been approved for various solid tumors including melanoma and non-small cell lung cancer. Bevacizumab, targeting VEGF, is approved for colorectal cancer and other solid tumors. While codrituzumab specifically targets GPC3, which is not mentioned in the provided context as having an FDA-approved counterpart, the general approach of using monoclonal antibodies to target specific proteins in solid tumors is well-established in oncology.

What other types of research exist?

Promising alternatives to Codrituzumab for solid tumors include immune checkpoint inhibitors like Pembrolizumab and Atezolizumab, which have shown efficacy in various cancers. Additionally, targeted therapies such as Infigratinib for FGFR2 gene fusions in cholangiocarcinoma and Lutetium-177-PSMA-617 for prostate cancer are notable. Combination therapies involving monoclonal antibodies and chemotherapy or other targeted agents are also being actively researched and may offer new treatment options in 2024.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had GPC3-directed immunotherapy.

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I do not have uncontrolled seizures.

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I do not have any infections that are currently uncontrolled.

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I do not have anti-codrituzumab antibodies.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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.

0 / 10Eligibility criteria met

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.