The primary objective of the breast cancer study is to determine preliminary efficacy through overall response rate. Credit: Ewa Krawczyk, National Cancer Institute Georgetown Lombardi Comprehensive Cancer Center, National Institutes of Health / Flickr (Creative Commons).

Clinical-stage oncology company Quadriga BioSciences has dosed the first patient in a Phase II trial to assess QBS10072S (QBS72S) for the treatment of patients with brain metastases of breast cancers.

Designed to assess the safety, tolerability and efficacy of QBS72S, the Phase II open-label study will enrol up to 35 patients.

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The primary objective of the study is to determine preliminary efficacy through overall response rate, while progression free survival, overall survival, duration of response and adverse events will be measured as secondary endpoints.

Phase II study principal investigator, Stanford Brain Tumor Center co-director and Stanford Medicine neurosurgery professor, Melanie Hayden Gephart said: “Breast cancer is one of the most common tumours to metastasize to the brain. Breast cancer brain metastases worsen prognosis, negatively affect quality of life, and currently available treatments are limited.

“QBS72S has shown promise in preclinical studies due to its targeted mechanism of action. I look forward to the opportunity to investigate this compound for patients in need.”

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Quadriga BioSciences CEO Gordon Ringold said: “The treatment of brain metastases is a significant unmet need in oncology, as no approved therapies exist.

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“With its ability to cross the blood brain barrier and target cancer cells, QBS72S has the potential to improve outcomes in these patients. We look forward to investigating this more closely with our colleagues at Stanford Medicine.”

In addition to brain metastases of breast cancers, QBS72S is being investigated for treating glioblastoma in the Phase II INSIGhT study at the Dana-Farber Cancer Institute.

Initial support for the breast cancer study was provided by the California Breast Cancer Research Program.