The FDA has cleared CStone Pharmaceuticals' investigational new drug application to begin a Phase II trial of its trispecific antibody CS2009 in advanced solid tumors. The multicenter trial will evaluate monotherapy and combination regimens across nine cancer types in Australia, China, and the U.S. Initial Phase I data showed a favorable safety profile and encouraging antitumor activity.
CD28 and CD38 have been identified as new therapeutic targets for peripheral T-cell lymphomas, with a trispecific antibody showing in vitro efficacy. The targets are expressed in 57% and 42% of PTCL cases respectively, covering most entities. Separately, low CD38 expression on circulating tumor-reactive T cells predicts better response to immune checkpoint inhibitors in lung cancer.
CStone Pharmaceuticals has received FDA clearance for its IND application to initiate a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGFA, and CTLA-4, in patients with advanced solid tumors across nine cancer indications.
CStone Pharmaceuticals received FDA IND clearance to initiate a Phase II trial of CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors across nine cancer indications.
CStone Pharmaceuticals received FDA IND clearance to begin a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGF, and CTLA-4, in advanced solid tumors across nine cancer indications.