Study of Treatment Aiming to Prevent Advanced Breast Cancer’s Spread to Bone Doses 1st Patient

Study of Treatment Aiming to Prevent Advanced Breast Cancer’s Spread to Bone Doses 1st Patient
GlycoMimetics announced that the first patient with advanced breast cancer has been dosed in a Phase 1b clinical trial investigating the ability of its small molecule inhibitor, GMI-1359, to stop breast cancer bone metastasis. The open-label, dose-escalation study (NCT04197999) is recruiting up to 12 patients whose breast cancer is positive for a hormone receptor (HR+) and has spread outside of the breast area (metastatic), including to the bone, but is stable or minimally progressive. Enrollment is ongoing at this proof-of-concept trial's sole site, Duke University Medical Center in Durham, North Carolina. “The initiation of enrollment is an important milestone in our exploration of GMI-1359 and its potential as a novel approach to treating metastatic cancer,” Helen Thackray, MD, a senior vice president and the chief medical officer of GlycoMimetics, said in a press release. “We’re ... look forward to learning more about its potential impact as clinical study advances.” Eligible participants must be receiving an endocrine-based treatment — either an aromatase inhibitor like anastrozole, a selective estrogen receptor degrader such as fulvestrant, or a selective estrogen receptor modulator like tamoxifen — and continue with it for the entire four-month study. Patients will receive up to three single doses of GMI-1359, administered via into-the-vein injection, and each dose will have a greater concentration of the treatment. This will help researchers determine the maximum tolerated dose in breast cancer patients. Once that is determined, patients will be given the maximum dose on three consecutive days. The starting dose was set in a completed Phase 1 clinical trial (NCT02931214), in which researchers measured the safety and tolerab
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