eligibility_summary
Eligible: adults ≥18 who consent, with measurable metastatic/advanced breast, NSCLC (EGFR mut/wt), gastric/GEJ, or CRC after failure/intolerance/no access to standard therapy, ECOG 0–1, life expectancy ≥3 months. Exclude: other active cancer ≤5y, hematologic malignancy, CNS primaries/active mets (allowed only if treated/stable and off high‑dose steroids ≥4 wks), significant lung disease, uncontrolled illness or IV infection, QTcF>470 ms, HIV/active HBV/HCV (some exceptions), pregnancy/lactation, no contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, first-in-human, multicenter study of DM001, a bispecific antibody–drug conjugate (ADC) given IV every 3 weeks in adults with advanced solid tumors (breast, NSCLC [EGFR-mutant or wild-type], gastric/gastroesophageal, colorectal). Mechanism: DM001 uses fully human common–light-chain antibodies to co-engage TROP2 and EGFR on tumor cells, enabling receptor-mediated internalization and targeted delivery of a cytotoxic payload to induce tumor cell death. Targets: TROP2-positive and EGFR-positive epithelial cancers, pathways include EGFR receptor tyrosine-kinase signaling and TROP2-associated proliferative signaling. Objectives: assess safety, tolerability, PK, and preliminary efficacy.