A Phase II Trial of PT-112 in Subjects with Thymoma and Thymic Carcinoma

Division Of Basic Sciences - Nci

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Abstract

PT-112, a first-in-class metallo-pyrophosphate conjugate, offers a unique set of properties of both cellular interaction and molecular antitumor mechanisms, including resistance to DNA repair pathways and induction of immunogenic cell death. In phase I trials, PT-112 has demonstrated clinical activity in patients with recurrent TETs. This single-arm phase II trial has been designed to evaluate the safety and clinical activity of PT-112 in patients with recurrent TETs. PT-112 is administered intravenously on days 1, 8 and 15 of a 28-day cycle at a dose of 360 mg/m2 until disease progression or development of intolerable adverse events. Five patients have been enrolled to date and 3 patients are evaluable for response. Disease stabilization has been observed in all cases. Adverse events include nausea, peripheral neuropathy, neutropenia and thrombocytopenia. NCT05104736