Phase 1 NTB-928 FRα×CD3 bispecific T-cell engager in relapsed/refractory ovarian carcinoma.

This Phase 1, multicenter, open-label dose-escalation and expansion study tests NTB-928, a fully human FRα (FOLR1)×CD3 bispecific T-cell engager antibody that redirects T cells to kill FRα-overexpressing tumor cells. The sponsor is TeneoSeven, Inc., and the primary goals are safety/tolerability (including dose-limiting toxicities), pharmacokinetics, immunogenicity, and early anti-tumor activity in relapsed/refractory ovarian carcinoma after prior platinum therapy. A key scientific angle is “tumor selectivity”: preclinical work on the NTB-928/TNB-928-style design highlights bivalent FRα binding and tuned CD3 engagement intended to favor high-FRα tumor cells while reducing cytokine release and off-tumor effects—an important issue for CD3-engagers. In this population, today’s care is sequential systemic therapy (platinum when sensitive; for platinum-resistant disease, options commonly include non-platinum chemotherapy, bevacizumab-containing regimens, and FRα-high targeted therapy such as mirvetuximab soravtansine in eligible patients), so this trial explores whether a T-cell–redirecting FRα approach can add activity after standard lines.