{
  "abstract": "Purpose:: This first-in-human, nonrandomized, multicenter study investigated nelistotug [anti–cluster of differentiation (CD) 96 monoclonal antibody (mAb)] as monotherapy (arm A), in combination with dostarlimab [anti–programmed cell death protein 1 (PD-1) mAb; arm B], and dostarlimab plus belrestotug [anti–T-cell immunoreceptor with Ig and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) mAb; arm F] in patients with recurrent or advanced solid tumors.\n\nPatients and Methods:: Patients received intravenous doses every 3 weeks of nelistotug 2.1 to 1,400 mg, nelistotug 70 to 1,400 mg plus dostarlimab 500 mg, or nelistotug 1,400 mg plus dostarlimab 500 mg plus belrestotug 400 mg in arms A, B, and F, respectively. Primary endpoints were dose-limiting toxicities (DLT) and adverse events (AE). Secondary endpoints included objective response rate, pharmacokinetics, and immunogenicity. Disease control rate and CD96 receptor occupancy were exploratory.\n\nResults:: Thirty-six, 33, and 3 patients were included in arms A, B, and F, respectively. No DLTs were observed in any arm, allowing for dose escalation to nelistotug maximum planned dose in arms A and B, with a recommended phase II dose of 1,400 mg. No treatment-related fatal AEs were observed. In arm B, 1 (3%) patient achieved a complete response and 1 (3%) achieved a partial response; no responses were observed in arms A and F. Nelistotug serum concentrations across doses were calculated to be sufficient to saturate the target in the tumor since >95% CD96 receptor occupancy was observed in peripheral blood immune cells.\n\nConclusions:: Nelistotug as monotherapy and in combination with dostarlimab and belrestotug had an acceptable safety and tolerability profile; however, efficacy was limited in this heavily pretreated patient population with advanced solid tumors.",
  "abstract_shown": true,
  "affiliations": [
    "Princess Margaret Cancer Centre, Toronto, Canada.",
    "The Angeles Clinic and Research Institute Inc, A Cedars-Sinai Affiliate, Los Angeles, California.",
    "Mary Crowley Cancer Research Center, Sarah Cannon Research Institute at Mary Crowley, Dallas, Texas.",
    "The University of Texas MD Anderson Cancer Center, Houston, Texas.",
    "The Ottawa Hospital Cancer Centre, Ottawa, Canada.",
    "Dana-Farber Cancer Institute, Boston, Massachusetts.",
    "Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.",
    "Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.",
    "Oncology Clinical Development, GSK, Cambridge, Massachusetts.",
    "Oncology Clinical Development, GSK, Waltham, Massachusetts.",
    "Oncology Clinical Development, GSK, Mississauga, ON, Canada.",
    "Clinical Pharmacology, Modeling and Simulation, GSK, Collegeville, Pennsylvania.",
    "Development Oncology Biostatistics, GSK, Stevenage, United Kingdom.",
    "Oncology Translational Medicine, GSK, Rockville, Maryland.",
    "Biomarkers and Analytical Platforms, GSK, Collegeville, Pennsylvania.",
    "Oncology Clinical Development, GSK, Collegeville, Pennsylvania.",
    "Oncology Clinical Development, GSK, Baar, Switzerland.",
    "National Cancer Center Hospital, Tokyo, Japan."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 19,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Lillian L. Siu",
      "orcid": "0000-0002-3500-0540"
    },
    {
      "affs": [
        1
      ],
      "name": "Omid Hamid",
      "orcid": "0000-0002-8238-4655"
    },
    {
      "affs": [
        2
      ],
      "name": "Reva Schneider",
      "orcid": "0009-0003-5570-7601"
    },
    {
      "affs": [
        3
      ],
      "name": "Jordi Rodon Ahnert",
      "orcid": "0000-0001-6467-3632"
    },
    {
      "affs": [
        4
      ],
      "name": "Scott A. Laurie",
      "orcid": "0000-0002-4888-0380"
    },
    {
      "affs": [
        5
      ],
      "name": "Frank Stephen Hodi",
      "orcid": "0000-0001-6825-091X"
    },
    {
      "affs": [
        6
      ],
      "name": "Dong-Wan Kim",
      "orcid": "0000-0001-5124-7132"
    },
    {
      "affs": [
        7
      ],
      "name": "Myung-Ju Ahn",
      "orcid": "0000-0002-5740-9654"
    },
    {
      "affs": [
        8
      ],
      "name": "Gary Carlson",
      "orcid": "0009-0006-3432-219X"
    },
    {
      "affs": [
        9
      ],
      "name": "Hussein Assi",
      "orcid": "0000-0002-5487-9319"
    },
    {
      "affs": [
        10
      ],
      "name": "Hamza Khan",
      "orcid": "0009-0002-0638-8563"
    },
    {
      "affs": [
        11
      ],
      "name": "Patrick Hanafin",
      "orcid": "0009-0003-7129-0404"
    },
    {
      "affs": [
        12
      ],
      "name": "Emily Moore",
      "orcid": "0009-0009-4352-4254"
    },
    {
      "affs": [
        13
      ],
      "name": "Madhu Ramaswamy",
      "orcid": "0000-0001-8870-5328"
    },
    {
      "affs": [
        14
      ],
      "name": "Reza Mozaffari",
      "orcid": "0000-0002-0738-7880"
    },
    {
      "affs": [
        11
      ],
      "name": "Stefan Zajic",
      "orcid": "0000-0002-9844-9951"
    },
    {
      "affs": [
        15
      ],
      "name": "Arindam Dhar",
      "orcid": "0000-0002-7929-0877"
    },
    {
      "affs": [
        16
      ],
      "name": "Ivan Diaz Padilla",
      "orcid": "0009-0001-6800-2462"
    },
    {
      "affs": [
        17
      ],
      "name": "Noboru Yamamoto",
      "orcid": "0000-0002-0787-2851"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/fadzgmkvx6wk9.bib",
  "cited_by": 0,
  "doi": "10.1158/1078-0432.ccr-25-4374",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13725324/",
  "id": "fadzgmkvx6wk9",
  "issns": [
    "1078-0432",
    "1557-3265"
  ],
  "landing_url": "https://doi.org/10.1158/1078-0432.ccr-25-4374",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Checkpoint Blockade"
    ],
    [
      "heading",
      "Clinical Trial Results"
    ],
    [
      "heading",
      "Clinical Trials: Immunotherapy"
    ],
    [
      "heading",
      "Combination Immunotherapy"
    ],
    [
      "heading",
      "Immunotherapy"
    ],
    [
      "heading",
      "Phase I clinical trials"
    ],
    [
      "openalex",
      "2730|Cancer Immunotherapy and Biomarkers"
    ]
  ],
  "openalex": "W7204454387",
  "pdf_url": "https://aacrjournals.org/clincancerres/article-pdf/doi/10.1158/1078-0432.CCR-25-4374/3825538/ccr-25-4374.pdf",
  "pmcid": "PMC13725324",
  "pmid": "42658188",
  "published": "2026-08-27",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/fadzgmkvx6wk9.ris",
  "sources": [
    {
      "first_seen": "2026-11-04T12:23:44Z",
      "native_id": "PMC13725324",
      "source": "pmc",
      "url": "https://doi.org/10.1158/1078-0432.ccr-25-4374"
    }
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|Cancer Immunotherapy and Biomarkers",
      "subfield": "oncology"
    }
  ],
  "title": "A Phase I First-Time-in-Human, Open-label Study of Nelistotug Administered to Patients with Advanced Solid Tumors",
  "title_text": "A Phase I First-Time-in-Human, Open-label Study of Nelistotug Administered to Patients with Advanced Solid Tumors",
  "type": "peer-reviewed",
  "updated_at": "2026-11-06T12:21:37Z",
  "url": "https://research.draconitic.com/paper/fadzgmkvx6wk9",
  "venue": "Clinical Cancer Research",
  "versions": []
}