Anti-PD-1 and anti-PD-L1 antibodies targeting the immuno-inhibitory PD-1 pathway (thus activating T cells) have achieved clinical success in many types of cancers. However, studies have shown that anti-TIGIT antibodies not only trigger T cells and Natural Killer(NK) cells, but they can also activate T cells to a greater extent than anti-PD-1 antibodies. Therefore, further clinical investigation of anti-TIGIT antibodies such as BAT6021 is warranted.~PD-1 and TIGIT are commonly co-expressed in T cells of the same tumor; thus, combining anti-TIGIT antibodies with PD-1/PD-L1 inhibitors may be a more effective cancer treatment. Indeed, anti-TIGIT antibodies have demonstrated synergy with anti-PD-1/PD-L1 antibodies in preclinical models. In addition, sponsor have shown that single administration of BAT1308 or BAT6021 could not effectively inhibit CT26 tumor growth in PD-1/TIGIT- humanized syngeneic mice; however, the combination treatment resulted in potent anti-tumor activity. Therefore, combined treatment with BAT6021 and an anti-PD-1/PD-L1 antibody like BAT1308 could improve therapeutic outcomes.
This first-in-human open-label, multi center, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of BAT6021 alone or in combination with BAT1308 (an anti-PD-1 antibody) in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.