Codrituzumab for Solid Tumors

Recruiting at3 trial locations

Overseen by Michael Ortiz, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: CNS tumor, Uncontrolled seizures, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot be on any current anti-cancer therapy or investigational agents to participate.

Research Team

Michael Ortiz, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Systemic Anticancer Therapy (e.g. Chemotherapy): Not Myelosuppressive: > 7 days must have elapsed from their last dose of anticancer therapy not known to be myelosuppressive (e.g. not associated with reduced platelet or ANC counts). Myelosuppressive: > 14 days must have elapsed from their last dose of known myelosuppressive anticancer therapy. Antibodies: > 21 days must have elapsed from the infusion of last anticancer antibody. Cellular Therapies: > 42 days must have elapsed from the completion of any type of cellular therapy, including modified T cells, NK cells, dendritic cells, etc.

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.

Exclusion Criteria

Patients who do not have tumor tissue available for GPC3 testing are not eligible for study entry.

I haven't taken high-dose steroids or immunosuppressants for over 14 days.

Patients with a baseline QTc > 480.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive codrituzumab with a 3+3 dose escalation design to determine the maximum tolerated dose (MTD)

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• Codrituzumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Codrituzumab Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Chugai Pharma USA

Industry Sponsor

Trials

9

Recruited

4,600+