First-in-human – Treatment for metastatic or recurrent solid tumors.

Phase 1 trial evaluating XRD-0394 in combination with radiation therapy for the treatment of metastatic, locally-advanced or recurrent solid tumors has started.
oncology-clinical-trials

XRad Therapeutics, a clinical stage biopharmaceutical company focused on developing dual kinase inhibitors for treating cancer, today announced that the first patient has been dosed in the company’s Phase 1 trial evaluating XRD-0394 in combination with radiation therapy (RT) for the treatment of metastatic, locally-advanced or recurrent solid tumors. XRD-0394 is a first-in-class, oral, dual kinase inhibitor of both ataxia-telangiectasia mutated (ATM) and DNA-dependent protein kinase (DNA-PK) and based on preclinical studies is designed to enhance the effectiveness of radiation therapies.

“More than 50% of cancer patients receive radiation therapy as part of their treatment regimen. Despite its widespread use, high unmet needs still exist in many tumor types,” said Tona Gilmer, PhD, president, chief executive officer and co-founder of XRad. “We look forward to continuing the development of XRD-0394 as we transition into clinical trials.”

The Phase 1 trial is an open-label, multicenter study designed to evaluate the safety and tolerability of single ascending doses of XRD-0394 administered with palliative RT in patients with metastatic, locally advanced, or recurrent cancer. Results from this study will inform the dosing regimen for the company’s planned Phase 1b study.

Radiation therapy is one of the most widely used approaches for treating cancer and works by damaging the DNA of tumor cells. ATM and DNA-PK play critical roles in DNA repair and become activated after exposure to radiation therapy. In preclinical studies, XRD-0394 improved the effectiveness of radiation therapy by blocking these two key repair enzymes.

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