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eligibility_summary
Adults 18–75 with histologically/cytologically confirmed advanced solid tumors, measurable disease (RECIST 1.1), ECOG 0–1, expected survival ≥12 weeks, able to consent, contraception required during treatment and 6 months after if of childbearing potential. Exclude: other malignancy in past 5 years, symptomatic CNS metastases, major surgery/severe trauma <4 weeks, high-dose steroids <2 weeks, substance abuse, pregnant/lactating, otherwise unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: FZ-AD004, an investigational antibody–drug conjugate (ADC) administered intravenously. Mechanism/type: Targeted cytotoxic therapy, a monoclonal antibody binds a tumor-associated surface antigen, is internalized, and releases a linked cytotoxic payload inside the cancer cell to induce cell death. This is classified as immunotherapy/targeted therapy. Cells/pathways targeted: Antigen-expressing tumor cells (advanced solid tumors). The precise antigen and payload are not disclosed in the listing, thus, the ADC is expected to act via antigen-mediated endocytosis with intracellular payload activity (e.g., DNA or microtubule damage depending on payload). Trial context: First-in-human Phase 1 dose escalation/expansion to determine safety, MTD/RP2D, PK, and preliminary efficacy.