Phase 1 AWT020 anti–PD-1–IL-2 fusion protein (checkpoint blockade + cytokine agonist)

This open-label Phase 1 study is determining the maximum tolerated dose and/or recommended Phase 2 dose of AWT020 given as intravenous monotherapy, while also characterizing safety, pharmacokinetics, immunogenicity, and preliminary antitumor activity. AWT020 is a bifunctional fusion protein from Anwita Biosciences that couples a PD-1–directed monoclonal antibody (releasing inhibitory checkpoint signaling on T cells) with an IL-2 cytokine payload designed to expand/activate antitumor lymphocytes. The eligible population is adults with advanced/metastatic, unresectable solid tumors that have progressed after available standard treatments (or where no standard treatment exists). The core scientific/commercial angle is whether “cis-delivering” IL-2 activity into PD-1–engaged immune synapses can retain IL-2 immune amplification while reducing the systemic toxicity that historically limited IL-2 therapy. In this refractory all-comers setting, today’s care is tumor-specific sequential systemic therapy (targeted therapy or immunotherapy when biomarker-eligible, plus chemotherapy and/or antibody-drug conjugates as later-line options), and this trial tests a next-generation immunocytokine approach aimed at deeper, more durable immune responses.