Phase 1/2a VBC106 FRα/MSLN-targeted topo1 inhibitor antibody-drug conjugate in solid tumors.

This first-in-human, multicenter, open-label Phase 1/2a study from VelaVigo Bio evaluates VBC106, an FRα (FOLR1)- and mesothelin (MSLN)-directed antibody-drug conjugate that delivers a topoisomerase I inhibitor payload (topo1i) to antigen-expressing tumor cells. FRα/MSLN is expressed in epithelial ovarian carcinoma (EOC), malignant pleural mesothelioma (MPM), and a substantial subset of non-small cell lung cancer (NSCLC) adenocarcinomas. Phase 1 uses a Bayesian optimal interval (BOIN) dose-escalation approach, with potential backfill cohorts, to define the maximum tolerated dose and/or recommended Phase 2 dose, with dose-limiting toxicities assessed over an approximately 21‑day window. Phase 2a includes dose optimization followed by cohort expansion to further characterize safety, tolerability, and preliminary efficacy at the selected dose in chosen advanced solid tumor malignancies. Eligible participants have unresectable advanced/metastatic solid tumors that have progressed after standard systemic therapy (or where standard options are not appropriate/tolerable), with ECOG 0–1 and measurable disease. The commercial/scientific angle is dual-antigen targeting (FRα + MSLN) paired with a clinically validated ADC payload class; today’s care for refractory metastatic solid tumors is sequential systemic therapy (tumor-specific chemo, targeted therapy when actionable alterations exist, and immunotherapy/ADCs where indicated), and this explores whether a dual-target topo1i ADC can widen the therapeutic window in heavily pretreated disease.