eligibility_summary
Key eligibility: Adults ≥18 with advanced/metastatic solid tumors lacking options, ≥1 extracranial measurable lesion (RECIST 1), ECOG 0–1, life expectancy ≥12 wks, contraception, not pregnant, consented. Exclude: prior CDH6 therapy, recent chemo/targeted (≤21d/5 HL), mAb/investigational (≤28d), radiotherapy, or major surgery, other malignancy, inadequate marrow/organ, CV risk, uncontrolled disease, recent/active infection or bleeding, neuropathy/mental disorder, pregnant/lactating, severe HS-20124 hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06763159 (Phase I, open-label). Intervention: HS-20124, a DAR-8 antibody–drug conjugate (ADC, monoclonal antibody linked to a cytotoxic payload) given IV every 21 days. Mechanism: HS-20124 binds Cadherin-6 (CDH6) on tumor cells, is internalized, and releases its cytotoxic payload intracellularly to kill CDH6-expressing cancer cells, effect is targeted delivery rather than checkpoint blockade. Targets: CDH6-positive tumor cells, cadherin-mediated cell adhesion pathway (CDH6, a calcium-dependent adhesion molecule) on advanced solid tumors. Objectives: assess safety, DLT/MTD, PK, and preliminary antitumor activity, dose-escalation (rolling-6) followed by dose expansion. Recruiting in China.