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New treatment option for Primary Extra-cranial Solid Tumor
Official 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
ClinicalTrials.gov ID: NCT04928677
What this study is testing
What is Codrituzumab?
Codrituzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary extra-cranial solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study to find out whether codrituzumab is a safe treatment that causes few or mild side effects in children and young adults who have solid tumors that express the protein GPC3. The researchers also want to study the way codrituzumab is absorbed, distributed, and cleared from the body.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 21
You may be able to join if
- Consent/Assent: All patients and/or their parents or legally authorized representatives must sign written informed consent; assent, when appropriate...
- Age: Patients must be aged 12 months up to but not including 22 years at the time of study registration. A patient who is 21 at the time of...
- Patients must have a diagnosis of a primary extra-cranial solid tumor that is recurrent or refractory to standard therapy.
- For the purposes of this study, the following definitions will be used:
- Refractory is defined as any tumor which progresses despite maximal standard therapies
You likely can't join if
- Patients receiving current anti-cancer therapy or investigational agents are not eligible for study entry.
- Patients who do not have tumor tissue available for GPC3 testing are not eligible for study entry.
- 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.
- people with a condition requiring systemic treatment with either corticosteroids (\>0.15 mg/kg daily prednisone equivalents) or other...
- Patients with documented CNS tumor, CNS metastasis, CNS ischemia and/or infarction, whether symptomatic or discovered incidentally without clinical...
See the full eligibility criteria
Who can join
- Consent/Assent: All patients and/or their parents or legally authorized representatives must sign written informed consent; assent, when appropriate, will be obtained according to institutional guidelines.
- Age: Patients must be aged 12 months up to but not including 22 years at the time of study registration. A patient who is 21 at the time of enrollment but turns 22 thereafter will still be considered eligible for the...
- Patients must have a diagnosis of a primary extra-cranial solid tumor that is recurrent or refractory to standard therapy.
- For the purposes of this study, the following definitions will be used:
- Refractory is defined as any tumor which progresses despite maximal standard therapies
- Recurrent (relapsed) is defined as a completion of planned therapy after which point the tumor recurs within 5 years of treatment. Additionally, any tumor which recurs twice is considered relapsed.
- Tumor GPC3 Expression: Patients must have demonstrated positive GPC3 expression via immunohistochemistry (IHC) on any prior tumor sample. Confirmation of GPC3 expression may include a diagnostic or relapsed sample, at a...
- Tumor GPC3 Expression: Patients must have demonstrated a minimum of 1+ GPC3 expression via immunohistochemistry (IHC) on any prior tumor sample. Confirmation of GPC3 expression may include a diagnostic or relapsed...
- Disease Status: Patients must have measurable disease based on RECIST 1.1.
- Performance Level: Patients must have Karnofsky Performance Score (for patients \> 16 years of age) or Lansky Performance Score (for patients ≤ 16 years of age) ≥ 50% assessed within 2 weeks of study enrollment.
- Neurological Deficits: Patients with neurologic deficits must have been stable and off of steroids for a minimum of 1 week prior to study entry; patients who are unable to walk because of paralysis, but who are up in a...
- Pregnancy/Contraception: Patients must not be pregnant or breast-feeding; females, excluding pre-menstrual, must have a negative serum or urine pregnancy test within 7 days prior to enrollment; males or females of...
- Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study; recovery is defined as all AEs, attributable to...
- 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.
- Radiation: Patients who have had radiation must have had their last fraction of:
- Local irradiation to the primary tumors or other limited sites (cumulative dose \ 14 days prior to registration.
- Local irradiation to the primary tumors or other sites (cumulative dose ≥ 40Gy), therapeutic 131I-MIBG or other radiopharmaceutical, and other substantial bone marrow radiation, \> 42 days prior to registration.
- Craniospinal irradiation, radiation to \> 50% of pelvis, or total body irradiation \> 120 days prior to registration.
- Stem Cell Infusions: With or without TBI
- 84 days must have elapsed from an allogeneic bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion and patients must also not have any evidence of acute or chronic GvHD.
- 42 days must have elapsed from an autologous stem cell infusion including boost infusion.
- Supportive Therapies: Patients must be off all growth factor(s) that support platelet, red blood cell, or white blood cell count, number or function for at least 7 days prior to registration (e.g. filgrastim...
- Organ Function: Patients must have documented within 14 days of registration and within 7 days of starting treatment the following:
- Hgb \> 8 gm/dL (may be transfusion-supported)
- Platelet count \> 50,000/mm\^3 (transfusion independent)
- Absolute neutrophil count (ANC) \> 1000/mm\^3
- INR ≤ 2.5
- Total Bilirubin (sum of conjugated + unconjugated) ≤ 3 times institutional upper limit of normal (ULN) for age
- Aspartate aminotransferase (AST) ≤ 5 times institutional ULN for age
- Alanine Aminotransferase (ALT) ≤ 5 times institutional ULN for age
- Serum albumin ≥ 2 g/dL
- GFR ≥ 50 mL/min/1.73 m\^2 as measured using urine creatinine clearance, serum cystatin c, radioisotope GFR, or serum creatinine as measured by the Schwartz equation (Refer to Schwartz, et al. J Am Soc Neph, 2009)
What rules you out
- Patients receiving current anti-cancer therapy or investigational agents are not eligible for study entry.
- Patients who do not have tumor tissue available for GPC3 testing are not eligible for study entry.
- 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.
- people with a condition requiring systemic treatment with either corticosteroids (\>0.15 mg/kg daily prednisone equivalents) or other immunosuppressive medications, if used to modify immune adverse events related to...
- Patients with documented CNS tumor, CNS metastasis, CNS ischemia and/or infarction, whether symptomatic or discovered incidentally without clinical symptoms, will be excluded from study participation.
- Patients with a baseline QTc \> 480. (as measured using Bazett formula; Refer to Bazett, Heart, 1920).
- Patients with an inability to return for follow-up visits, obtain follow-up studies required to assess toxicity to therapy, or comply with the safety monitoring requirements.
- Patients who have an uncontrolled infection are not eligible.
- Patients who have received a prior solid organ transplantation are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; New York, New York, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.