eligibility_summary
Eligibility: Advanced/metastatic solid tumors lacking SOC or refractory (≥1 line), measurable disease (RECIST 1.1), ECOG 0–1, >3‑mo life expectancy, normal ECG, adequate organ function, biopsyable lesion in Ph1B, contraception required. Key exclusions: recent therapy, unresolved tox, prior CTLA‑4/CCR8/CD25/TIGIT Fc agents, QTcF>470 ms, active HBV/HCV/TB or uncontrolled HIV, major CV disease, autoimmune/IBD, transplants, pregnancy, systemic steroids, other active cancers, unstable brain mets.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06258304 tests GIGA-564, a minimally blocking anti-CTLA-4 monoclonal antibody (immune checkpoint–targeting biologic) given IV every 3 weeks in adults with advanced/metastatic solid tumors (Phase 1 dose escalation/expansion). Mechanism: GIGA-564 binds CTLA-4 on T cells while minimally blocking ligand engagement (CD80/CD86), aiming to fine-tune CTLA-4 checkpoint modulation to enhance anti-tumor immunity with potentially reduced toxicity. Target cells/pathways: CTLA-4 pathway on regulatory T cells (Tregs) and activated T cells in the tumor microenvironment, downstream effects on APC–T cell costimulation (CD28–CD80/86), relieving Treg-mediated suppression and promoting effector T-cell activation.