A new clinical trial has been initiated to combat solid tumors in children and young adults, spearheaded by Penn State College of Medicine, the Beat Childhood Cancer Research Consortium, Four Diamonds, and Senhwa Biosciences, Inc. The trial will evaluate the investigational drug silmitasertib in combination with FDA-approved chemotherapies, focusing on safety, tolerability, and efficacy in treating cancers such as neuroblastoma, Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma.
The primary goal of this study is to establish a recommended dosage for silmitasertib when used alongside chemotherapy. The trial, identified as NCT06541262, plans to enroll up to 114 participants across the Beat Childhood Cancer Research Consortium member hospitals nationwide.
Developing Targeted Therapies
"This clinical trial is a critical piece in understanding if the new medicine is safe to use in children as well as the mechanism of how the medicine works against the tumor cells," said Dr. Chandrika Behura, study chair, Four Diamonds researcher, and associate professor of pediatrics at the College of Medicine. "It is very important to develop the right combination of medicines that can be the most toxic to cancer cells, but the least harmful to the normal cells around them."
The study will assess the safety and effectiveness of the treatment based on individual patient responses and the duration of disease control, with the aim of developing novel therapeutic approaches. Silmitasertib, provided by Senhwa Biosciences, is a potential treatment option for childhood cancers, and this trial aims to realize its therapeutic value in an area of urgent need.
Collaborative Effort
Dr. Giselle Sholler, division chief of pediatric hematology/oncology and director of pediatric oncology research at the College of Medicine and chairperson of the Beat Childhood Cancer Research Consortium, stated, "We are thrilled to be able to move this important research forward on a larger scale. The insights gained from this trial will help not only local patients and their families but can lead to new therapies that can help children throughout the US and internationally."
Funding for the clinical trial is provided by the Beat Childhood Cancer Foundation and the Little Warrior Foundation, with additional support from Four Diamonds for Behura’s research leading up to the trial.
Aiming for Optimized Care
"By expanding our research and increasing clinical trials, we are exploring immunotherapy, cellular therapy and precision medicine to deliver the most optimized care to each unique patient," said Dr. Yatin Vyas, chair of the Department of Pediatrics at the Children’s Hospital, and vice president of Penn State Health Children’s.
Jin-Ding Huang, PhD, CEO of Senhwa Biosciences, Inc., added, "We are greatly honored to collaborate with the Penn State College of Medicine and Beat Childhood Cancer Research Consortium... We appreciate for having the opportunity of providing Silmitasertib as a potential effective treatment and look forward to realizing its therapeutic value in this urgently needed field for childhood cancers though this study."
