DM002 (anti‑MUC1/HER3 BsADC; Topo‑I payload) Shows 20% PRs and 73% DCR in Early Solid-Tumor Readout

DM002 is a bispecific antibody–drug conjugate targeting MUC1 and HER3 (average DAR≈8) and delivering a DNA topoisomerase I inhibitor payload (BCPT02) via the BLD1102 linker/payload system; it was evaluated in a first-in-human 3+3 dose-escalation trial (NCT06751329) in advanced solid tumors after a mean 2.5 prior lines (n=29; imaging-evaluable n=15; Q3W 1–6.0mg/kg; data cutoff 28 Dec 2025). The MTD was 4.5mg/kg with 3 DLTs in 2 patients at 6.0mg/kg; 65.5% had TRAEs and grade≥3 TRAEs occurred in 12/29 (notably neutropenia 9, leukopenia 5, thrombocytopenia 4, anemia 3; febrile neutropenia 2), with no ILD reported. Among RECIST-evaluable patients, ORR was 20% (3/15 PRs: prostate, ovarian at 3.0mg/kg; pancreatic at 4.5mg/kg) and DCR was 73% (3 PR + 8 SD); in pancreatic cancer specifically, 1/8 had PR and 5/8 had SD (DCR 75%)—a signal that sits in the ballpark of later-line pancreatic benchmarks where nal‑IRI+5‑FU/LV reports ORR ~16% in NAPOLI‑1 (post‑gemcitabine) and ~10% in some real‑world series, though cross‑trial comparisons are fragile given mixed lines and small n here.