eligibility_summary
Adults ≥18 with measurable disease (RECIST 1.1), ECOG 0–1, adequate organ/marrow, prior-treatment AEs resolved to ≤Grade 1 (except alopecia, Grade 2 neuropathy). Controlled HIV on ART allowed. Exclude: active CNS mets/meningitis, second malignancy, HBV/HCV, TB, active/uncontrolled or severe infection ≤4w, chronic liver disease/cirrhosis, active autoimmune needing systemic Tx ≤2y, prior GI‑102–like IO, immunodeficiency/steroids ≤2w, systemic therapy ≤4w, RT ≤2w (limited palliative ok), live vaccine ≤4w, hypersensitivity. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05824975 (KEYNOTE-G08) tests GI-102 alone and with standard agents, pembrolizumab, or trastuzumab deruxtecan in advanced solid tumors. GI-102 is a bispecific immunocytokine/fusion protein (CD80–IgG4 Fc–IL‑2 variant) that binds CD80 and IL‑2Rβγ. Mechanism: the CD80 moiety targets tumor/immune cells and functionally blocks CTLA‑4 on Tregs, the IL‑2 variant lacks IL‑2Rα binding, sparing Tregs while preferentially expanding/activating CD8+ T cells and NK cells via IL‑2Rβγ signaling. Combos and MoA: doxorubicin (anthracycline/topoisomerase II inhibitor), paclitaxel (microtubule stabilizer), eribulin (microtubule inhibitor), bevacizumab (anti‑VEGF‑A), trastuzumab deruxtecan/T‑DXd (HER2 ADC with topo I payload), pembrolizumab (anti‑PD‑1). Targets: IL‑2/IL‑2Rβγ pathway, CTLA‑4 on Tregs, CD8+ T and NK activation, HER2, VEGF/angiogenesis, PD‑1 axis, DNA replication, microtubule dynamics.