eligibility_summary
Inclusion: Histologically confirmed unresectable/metastatic solid tumor refractory/intolerant/no standard, measurable disease (RECIST), tumor tissue for expansion, life expectancy ≥12 wks, ECOG 0–1, adequate organ function, contraception. Exclusion: prior CCR8 inhibitor/hypersensitivity, recent systemic therapy or live vaccines, CNS primary/unstable mets, autoimmune/immunodeficiency, active infection, cognitive limits, recent major surgery, severe CV/ILD/pneumonitis/effusions, unresolved AEs, other recent cancers, pregnant/breastfeeding, other protocol criteria.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, first‑in‑human, open‑label dose‑escalation/expansion study in advanced solid tumors. Intervention: HC006, a therapeutic monoclonal antibody immunotherapy targeting C‑C chemokine receptor 8 (CCR8). Mechanism: HC006 binds CCR8 on tumor‑infiltrating regulatory T cells (Tregs) and is designed for enhanced antibody‑dependent cell‑mediated cytotoxicity (ADCC), enabling Fcγ receptor–mediated killing (e.g., by NK cells) to selectively deplete CCR8+ Tregs, reduce intratumoral immunosuppression, and boost antitumor immunity. Targets: CCR8 pathway on intratumoral Tregs within the tumor microenvironment, ADCC effector pathway engagement. Objectives: assess safety, tolerability, PK, immunogenicity, and preliminary efficacy, determine MTD and recommended dose.