Theratechnologies has dosed the first subject in part three of its Phase I clinical study of sudocetaxel zendusortide for advanced ovarian cancer.
After the antitumor activity was demonstrated in parts one and two, the company enrolled the first patient in part three.
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The announcement comes after the US Food and Drug Administration (FDA) accepted the company’s amended protocol for the Phase I trial in June this year.
The updated protocol is designed to enhance sudocetaxel zendusortide’s therapeutic window and prolong the duration of treatment.
Upon the establishment of initial dose safety in the first six subjects, the trial intends to enrol a total of 16 patients in part three.
Sudocetaxel zendusortide, an investigational, first-in-class peptide-drug conjugate, is designed to target sortilin. It boosts the internalisation and delivery of a cytotoxic payload into cancer cells directly.
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By GlobalDataIt received fast-track designation from the FDA as a monotherapy to treat all sortilin-positive recurrent advanced solid tumours that are refractory to standard therapy.
Theratechnologies senior vice-president and chief medical officer Christian Marsolais said: “We are excited to dose the first of six patients in part three of the Phase 1 trial of sudocetaxel zendusortide with its modified design and dosing regimen.
“We look forward to building on the efficacy we’ve observed so far, which is mainly long-term disease stabilisation in a number of advanced patients. This first-patient-dosed milestone thus extends the momentum of our oncology clinical development programme.”
