NEW YORK – Marengo Therapeutics on Thursday said it has started treating patients with certain types of breast cancer in a Phase Ib/II trial of its T-cell agonist, invikafusp alfa, plus Gilead's TROP2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy).
The STARt-002 trial will begin with a safety lead-in portion in breast cancer to determine the optimal dose for the combined agents. Then, it will enroll two cohorts of breast cancer patients in the dose-expansion portion: metastatic triple-negative breast cancer and hormone receptor (HR)-positive, HER2-negative metastatic breast cancer. Study investigators will evaluate the safety and efficacy of the combination and track progression-free and overall survival.
Researchers will enroll approximately 50 patients in the study, which is currently open at Massachusetts General Hospital, Sarah Cannon Research Institute, and Princess Margaret Cancer Centre.
Invikafusp alfa is designed to selectively activate Vβ6 and Vβ10 T cells, a subset of T cells prevalent among tumor infiltrating T cells, to enhance anti-tumor immunity and enable durable tumor clearance.
"As presented in recent [medical] meetings, invikafusp clearly demonstrates promising monotherapy activity in PD-1 resistant tumors including microsatellite stable colorectal cancer and PD-1 negative non-small cell lung cancer," Kevin Chin, chief medical officer of Marengo, said in a statement. "These data reinforce our belief that invikafusp could serve as a best-in-class immunotherapy backbone for multiple tumor types, particularly when paired with ADCs in immunologically cold tumors such as breast cancer."
Marengo, based in Cambridge, Massachusetts, is also studying invikafusp alfa as a monotherapy in advanced solid tumors in a Phase I/II trial. That study involves patients with high tumor mutational burden, microsatellite instability, DNA mismatch repair, and virally associated tumors.