Phase 1a/1b BG-C0979 ADAM9-targeted ADC with Topo1 inhibitor payload ± tislelizumab

This first-in-human, multicenter, open-label Phase 1a/1b study tests BG-C0979, an ADAM9-targeted antibody-drug conjugate (ADC) delivering a DNA topoisomerase I (Topo1) inhibitor payload, sponsored by BeOne Medicines (BeiGene). Phase 1a uses monotherapy dose escalation followed by safety expansion to define tolerability, pharmacokinetics, and a recommended dose for expansion; Phase 1b Part A then optimizes and expands monotherapy, while Part B expands a combination of BG-C0979 with tislelizumab, BeOne’s PD-1 (CD279) monoclonal antibody. The population is selected advanced/metastatic, unresectable solid tumors: Parts A/1a focus on patients who have exhausted or lack appropriate standard systemic options, while Part B is positioned for first-line advanced/metastatic settings in selected tumors. Scientifically, the key angle is whether ADAM9-directed delivery can widen the therapeutic window of a Topo1 payload and whether adding PD-1 blockade can deepen responses. Today’s care for most metastatic solid tumors remains tumor-specific systemic therapy (targeted therapy when actionable drivers exist, immunotherapy for eligible tumors, and chemo/ADCs in later lines), with sequencing based on biomarker and histology.