The clinical trial is expected to enrol up to 114 individuals. Credit: Daenin/Shutterstock.

Senhwa Biosciences has enrolled the first subject for a Phase I/II trial at Penn State Health Children’s Hospital to evaluate the efficacy of silmitasertib (CX-4945) in conjunction with chemotherapy to treat children and young adults with relapsed or refractory solid tumours.

The study focuses on establishing a recommended dosage and assessing tolerability, safety and efficacy, particularly for cancers such as neuroblastoma and sarcomas.

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The clinical trial is expected to enrol up to 114 individuals via the Beat Childhood Cancer Research Consortium member hospitals.

It aims to develop new therapeutic approaches by monitoring individual responses and disease control duration.

The trial is supported with funding from the Beat Childhood Cancer Foundation and the Little Warrior Foundation, with previous research funding from Four Diamonds.

Senhwa Biosciences CEO Jin-Ding Huang said: “We are greatly honoured to collaborate with the Penn State College of Medicine and Beat Childhood Cancer Research Consortium, which have been diligently fighting childhood cancers by infusing invaluable resources from over 50 universities and children’s hospitals across the US for the clinical study.

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“We appreciate having the opportunity to provide silmitasertib as a potentially effective treatment and look forward to realising its therapeutic value in this urgently needed field for childhood cancers through this study.”

Last month, the US Food and Drug Administration (FDA) granted orphan drug designation (ODD) to silmitasertib for neuroblastoma treatment.

Additionally, it received a rare paediatric disease designation in September.

The drug has also been designated for other indications, including medulloblastoma, biliary tract cancer and cholangiocarcinoma.

Neuroblastoma is diagnosed mostly before five years, with a high rate of metastasis at symptom onset and a 20-year survival rate of only 30%.