eligibility_summary
Inclusion: >=18, unresectable mCRC adenocarcinoma, non-MSI-H/dMMR, >=1 prior chemo, ECOG 0-1, measurable disease, adequate renal/liver/hematologic function. Exclusion: allergy, recent anticancer/ICI/investigational therapy or strong CYP3A4 meds, obstruction/ascites, ILD/pneumonitis, steroids/immunosuppression/autoimmune dz, cardiac/QTc/LVEF<50, active CNS/LM/spinal compression, recent other cancer, active infection, pregnant/lactating, other significant issues/prohibited meds.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests SR-8541A + botensilimab + balstilimab in refractory MSS-CRC. Drugs/types and MoA: • SR-8541A: oral small‑molecule immunomodulator, specific mechanism not detailed in the registry, used to enhance response to checkpoint blockade. • Botensilimab: next‑gen anti‑CTLA‑4 monoclonal antibody (Fc‑enhanced IgG1) checkpoint inhibitor, augments T‑cell priming and depletes intratumoral Tregs via Fc‑mediated effector functions. • Balstilimab: anti‑PD‑1 monoclonal antibody (IgG4) checkpoint inhibitor, blocks PD‑1/PD‑L1/PD‑L2 to restore effector T‑cell function. Targeted cells/pathways: PD‑1 and CTLA‑4 immune checkpoints on T cells (effector CD8+ T cells, Tregs), FcγR+ myeloid cells for Treg depletion, antigen‑presenting cells/dendritic cells for priming. Goal: convert “cold” MSS‑CRC (including liver mets) to immune‑responsive.