NEW YORK – Theratechnologies on Wednesday said it has dosed the first patient in a Phase I clinical trial of its investigational peptide drug conjugate, TH1902, for patients with sortilin (SORT1)-positive solid tumors.
The Phase I trial comprises a dose-escalation portion, in which researchers will assess the drug's safety, pharmacokinetics, preliminary clinical efficacy, and maximum tolerated dose in patients with solid tumors. Once the maximum tolerated dose is established, Theratechnologies will enroll an additional group of patients with endometrial, ovarian, colorectal, pancreatic, and triple-negative breast cancers, which are tumor types known to express the SORT1 biomarker.
Though in this Phase I clinical trial the Montreal-based drugmaker will not initially enroll patients based on variable SORT1 expression on their tumors, a company spokesperson said Theratechnologies will determine, based on efficacy data from the study, whether to take a biomarker-restricted approach to enrollment in the future.
TH1902 is designed in accordance with Theratechnologies' SORT1 Technology, an approach to drug development that involves attaching a novel SORT1-targeting peptide to an existing anti-tumor drug, such as a chemotherapy agent or a tyrosine kinase inhibitor.