Phase 1 NEOK002 EGFR×MUC1 bispecific ADC with topoisomerase-1 inhibitor payload

NEOK Bio’s first-in-human, open-label Phase 1 study (NCT07612189) evaluates NEOK002, an EGFR- and MUC1-binding bispecific antibody-drug conjugate (ABL209) carrying an exatecan-class topoisomerase I inhibitor payload to drive targeted DNA-damage after tumor-cell binding and internalization. The trial runs as sequential dose escalation with backfill (Part A) followed by dose expansion at the recommended dose (Part B), focusing on safety/tolerability, pharmacokinetics, and early anti-tumor signals in selected locally advanced unresectable or metastatic solid tumors. Eligibility is geared to progressive disease where no standard therapy is available, with typical Phase 1 requirements such as measurable disease and ECOG 0–1, and it excludes recent exposure to a topo-1–payload ADC (a practical issue given how common T-DXd-class drugs are across tumors). Scientifically, the “two-antigen” format aims to widen the therapeutic window versus single-target EGFR or MUC1 ADCs by improving tumor selectivity while retaining high payload delivery. In this setting, today’s care is largely clinical trials and individualized salvage regimens (often chemo, targeted therapy, or immunotherapy when a driver/biomarker exists), and this tests whether bispecific antigen recognition can make a topo-1 ADC usable in broader solid-tumor populations.