NCT04400851

Sintilimab in the Treatment of Advanced and Refractory Pediatric Malignant Tumors

Sintilimab in the Treatment of Advanced and Refractory Pediatric Malignant Tumors-A Phase I Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-label and phase I clinical study. The standard 3 + 3 group design was performed. Patients were enrolled by the design of phase I study standard. Sintilimab was divided into three dose levels: 1 mg / kg, 3 mg / kg, and 10 mg / kg. Dose escalation was carried out from the first level of sintilimab. The study is to evaluate the safety, including dose limited toxicity (DLT) in the treatment of advanced, recurrent, and refractory childhood cancer.

Detailed description

Malignant tumors are the second leading cause of death in China after accidental casualties, which is consistent with developed countries in Europe and America. Sintilimab is a human monoclonal antibody against PD-1 receptor which was developed in China. It can block the binding of PD-1 of T-lymphocyte and PD-L1 on the surface of tumor cells, release the immunosuppression of tumor cells on immune cells, making immune cells play the role of anti-tumor cell immunity again and kill tumor cells. In the past, the development of immunocheckpoint drugs mainly focused on adult cancer. Immunocheckpoint inhibition has achieved many successes in the adult population, including metastatic melanoma, non-small cell lung cancer, Hodgkin's lymphoma, bladder cancer and head and neck cancer. In the past, the development of immunocheckpoint drugs mainly focused on adult cancer. Immunocheckpoint inhibition has achieved many successes in adult population. However, some results of the clinical trials of immunocheckpoint inhibitors in children are also promising especially in Hodgkin's lymphoma. The investigators aimed to determine the maximum tolerable dose and effectiveness in pediatric malignant tumors, so as to lay the foundation for the future phase II / III clinical research.

Conditions

• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	Patients were enrolled by the design of phase I study standard. Sintilimab was divided into three dosage levels: 1 mg / kg, 3 mg / kg, and 10 mg / kg. The first level of sintilimab was followed by dose escalation

Timeline

• Start date: 2020-08-11
• Primary completion: 2021-10-10
• Completion: 2021-12-10
• First posted: 2020-05-26
• Last updated: 2020-09-03

Locations

1 site across 1 country: China