Challenges to addressing the unmet medical needs for immunotherapy targeting cold colorectal cancer.

The list of completed clinical trials reflecting the non-clinical strategies includes the following: A phase I study ( NCT02650713 ) in which a T-cell bispecific antibody and CEA combined with atezolizumab (targeting PD-L1) in CEA-positive solid tumors, indicating 20% partial response (PR) and 50% stable disease (SD)[ 69 ]; a phase I/II study ( NCT03711058 ) with a combination of copanlisib (PI3K inhibitor) and nivolumab (anti-PD-1 antibody) targeting relapsed/refractory MSS CRC, with a decreasing trend of CD4+ T-lymphocytes mainly comprised of Treg and helper subsets[ 70 ]; a phase Ib study ( NCT03977090 ) evaluating the safety and preliminary efficacy of fruquintinib (VEGF inhibitor) with geptanolimab (anti-PD-1 antibody) targeting metastatic CRC, indicating 26.7% ORR, 80% disease control rate (

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