eligibility_summary
Eligible: adults 18–75, ECOG 0–1, life ≥3 mo, advanced/metastatic cancer after standard therapy failure or unsuited, ≥1 measurable lesion (non-CNS), adequate organs, negative pregnancy test, effective contraception to 6 mo post-dose. Key exclusions: recent anti-tumor/immunomodulatory therapy or trial, prior TIGIT/PVRIG/CD96, symptomatic CNS mets, other malignancy ≤3 y, active autoimmune/ILD/IBD, serious infection/surgery/bleeding, uncontrolled HTN/DM, active HBV/HCV/HIV/immunodef, transplant, unresolved >G1 tox, live vaccine ≤4 w, severe mAb allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05868876 tests a combination of two immune checkpoint antibodies in advanced solid tumors. Drugs/mechanisms: 1) AK127: TIGIT-targeting IgG1 monoclonal antibody with intact Fc. It blocks TIGIT interactions with CD155 (PVR) and CD112 (Nectin-2), relieving TIGIT-mediated suppression, enhancing CD8+ T-cell activity, and leveraging Fc effector function to enable NK cell–mediated depletion of TIGIT-high intratumoral Tregs. Type: monoclonal antibody. 2) AK104 (cadonilimab): humanized IgG1 bispecific antibody to PD-1 and CTLA-4, blocks PD‑1/PD‑L1/PD‑L2 and CTLA‑4/B7.1‑B7.2 to boost T-cell priming and effector function. Type: bispecific antibody. Targeted cells/pathways: TIGIT–PVR axis (T cells/Tregs/NK cells, APCs), PD‑1/PD‑L1/PD‑L2 (exhausted T cells, tumor/APCs), CTLA‑4–B7 (T cells/APCs). Goal: reverse tumor immunosuppression, activate CD8+ T and NK cells, reduce suppressive Treg activity.