NEW YORK – Triumvira Immunologics said on Thursday it had begun treating patients in a Phase II trial of its autologous T-cell therapy, TAC01-HER2, in HER2-positive gastric and gastroesophageal junction cancers.
The firm began the potentially registrational Phase II portion of the TACTIC-2 study, which is evaluating TAC01-HER2 as a monotherapy and in combination with Merck's Keytruda (pembrolizumab) in HER2-positive gastric cancers. Deyaa Adib, chief medical officer of Triumvira Immunologics, said in a statement that these tumor types were identified based on positive results from the Phase I portion of the study in solid tumors.
Researchers will enroll 110 patients total in the trial. Those enrolled in the Phase II portion will be screened for a HER2 expression score of 2+ or 3+ by immunohistochemistry and FISH. TAC01-HER2 was developed using Triumvira's T-cell Antigen Coupler (TAC) technology and is designed to work with T-cell receptors to help a patient's T cells recognize and attack cancer cells.
"Despite considerable advances in the oncology field, HER2-positive gastric and gastroesophageal cancers remain difficult to treat, and new therapeutic options are urgently needed especially in later treatment lines in a growing patient segment," Adib said.