eligibility_summary
Eligible: Adults 18–75, ECOG 0–1, histologic locally advanced/metastatic TNBC not for radical therapy, failed standard therapy or systemic‑tx‑naïve, measurable disease, adequate organs, life ≥12 wks, tumor tissue, contraception. Exclude: significant prior toxicities (≥G2, ≥G3 irAEs), neuropathy ≥G2, HbA1c ≥8%, eye risk, ILD/pneumonitis, CNS mets/uncontrolled disease, recent therapy/immunosuppression/investigational/P‑gp/CYP3A4/vaccines/surgery, prior transplant/nectin‑4 ADC, hypersensitivity, PE/major CV/CVA, active autoimmune, other cancer, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label trial in locally advanced/metastatic triple‑negative breast cancer testing 9MW2821 alone or with a PD‑1 inhibitor. 1) Drugs/mechanisms: • 9MW2821: antibody‑drug conjugate (ADC) directed at Nectin‑4 (PVRL4). Upon binding and internalization, it releases a microtubule‑disrupting cytotoxic payload (MMAE‑type), causing mitotic arrest and tumor cell death, and may promote immunogenic cell death. • PD‑1 inhibitor: monoclonal antibody checkpoint blocker that prevents PD‑1/PD‑L1 signaling to restore and enhance T‑cell antitumor activity. 2) Targets: • Tumor cells expressing Nectin‑4, intracellular microtubule pathway. • Immune pathway: PD‑1 on exhausted T lymphocytes (and PD‑L1 on tumor/immune cells), boosting cytotoxic T‑cell function in the tumor microenvironment.