A Phase 1, Open-Label, Dose Escalation Study of TH1902 in Patients with Advanced Solid Tumors and Expansion in Patients with Triple Negative Breast Cancer, Gynecological Cancer, Colorectal cancer, and Pancreatic Cancer.
Even though this study is a Phase 1 it received FDA Fast Track Approval on February 4, 2021. An excerpt from the News Release announcing the fast-track status states:
“Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ TechnologyTM and further supports the future development of TH1902. The designation, which applies to all solid tumors expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted, and potentially more effective and better-tolerated therapies for cancer,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.
You can read more about the significance of FDA Fast-track approval in the News Release for this new and innovative technology on our webpage.
This study is designed to evaluate the maximum tolerated dose and preliminary anti-tumor activity of TH1902 administered once every 3 weeks in patients with advanced solid tumors refractory to available anti-cancer therapies.
SORT1+ technology developed by Theratechnology is a peptide (amino acid chain) which specifically targets sortilin (SORT1) receptors. These receptors regulate the transport of proteins into cells and through various metabolic pathways. SORT1 plays a significant role in protein transport making it an attractive target for cancer drug development.
Systemic chemotherapy normally enters the cells by passive diffusion and is not targeted to only cancer cells. It targets normal healthy tissue leading to significant toxicity. This can lead to development of dose limiting toxicities which can further lead to dose reductions or withdrawal from therapy.
TH1902 is a peptide with molecules of docetaxel (chemotherapy) attached. SORT1 receptors actively transport TH1902 directly into cancer cells where it delivers the cytotoxic payload into cancer cells causing cellular death while sparing normal healthy tissues. TH1902 also helps prevent development of drug resistance allowing therapies to work for longer periods.
If you are interested in more information on this study, please contact us. Refer to the Theratechnology Study Protocol th1902-CTR-0001. You can also find information on this study by going to clinicaltrials.gov website and searching for NCT04706962.