A Phase 1/2 Trial of VX15/2503 in Children Adolescents or Young Adults With Recurrent or Relapsed Solid Tumors
Investigating the Safety and Dosage of an Investigational Antibody in Treating Recurrent Solid Tumors in Children
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer,Solid Tumor
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Age: 1 years - 30 years
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Gender: All
Parts A: Patients with recurrent or refractory solid tumors are eligible, excluding central nervous system (CNS) tumors; patients must have had histologic verification of malignancy at original diagnosis or relapse
Part B: Patients with recurrent or refractory osteosarcoma are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse
Parts A: Patients must have either measurable or evaluable disease
Part B: Patients must have measurable disease
Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
Patients must not have received prior exposure to VX15/2503
Exclusion Criteria
Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy
Patients receiving systemic corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of systemic corticosteroid; Note: patients who are using topical or inhaled corticosteroids are eligible
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)
Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
Patients who have an uncontrolled infection are not eligible
Patients who have received a prior solid organ transplantation are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
This study investigates the effects of an investigational antibody in treating children with solid tumors that have come back or do not respond to treatment. The purpose of this study is to find the best dose and understand the side effects of the investigational antibody. The study focuses on children with recurrent or refractory solid tumors, which means tumors that have returned after treatment or do not respond to treatment. It also looks at how well the investigational antibody works against osteosarcoma, a type of bone cancer.
Participants will receive the investigational antibody as an infusion into their veins every 14 days. The study will monitor for side effects and how the body processes the antibody, which is known as pharmacokinetics. This study will also check if the investigational antibody helps control the disease or shrink tumors in patients with osteosarcoma. Participants will not be paid for their participation.
- Who can participate: Children with recurrent or refractory solid tumors, excluding those with CNS tumors, can participate. They must have verified malignancy and measurable or evaluable disease, have recovered from prior treatments, and not have used the investigational antibody before.
- Study details: Participants will receive the investigational antibody through an intravenous infusion every 14 days. They will be monitored for side effects and how their body processes the antibody. The study aims to find the best dose and understand the side effects.
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