TH1902 is a PDC, where Theratechnologies’ proprietary peptide is linked to docetaxel, a well-established and well-characterized cytotoxic agent. The U.S. Food and Drug Administration (FDA) recently granted fast track designation to TH1902 to be developed as a single agent for the treatment of all advanced solid tumors expressing sortilin that are refractory to standard therapy. TH1902 is the Company’s lead PDC stemming from Theratechnologies’ SORT1+ Technology™ in oncology.
TH1902 is currently being evaluated in a Phase 1 clinical trial. The Phase 1 clinical trial includes a dose-escalating part to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies.
Once the MTD is determined, part 2 of the Phase 1 will be initiated, where additional patients with SORT1+ tumors will be enrolled into a basket design to evaluate the potential anti-tumor activity and safety of TH1902 in patients with multiple tumor types known to express sortilin.
Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center is the Lead Principal Investigator of the Phase 1 trial for TH1902.
The detailed Phase 1 study protocol is available at www.clinicaltrials.gov under the identifier number: NCT04706962.