{
  "abstract": "PURPOSE: Fibroblast activation protein (FAP) is an attractive target for radiopharmaceutical therapy. Phase I of the LuMIERE study (ClinicalTrials.gov, NCT04939610) investigated the safety of [177Lu]Lu-FAP-2286 (177Lu-FAP-2286) in heavily pretreated patients with advanced solid tumors and identified the recommended phase II dosage (RP2D). PATIENTS AND METHODS: LuMIERE is a prospective, open-label, nonrandomized, phase I/II, multicenter study. Phase I followed a Bayesian optimal interval design evaluating four escalating activity levels of 177Lu-FAP-2286 (3.70, 5.55, 7.40, and 9.25 GBq). Patients were selected by positive [68Ga]Ga-FAP-2286 (68Ga-FAP-2286, also known as [68Ga]Ga-HKG301) PET/CT imaging on all target lesions [maximum standardized uptake value (SUVmax) ≥1.5× SUVmean of mediastinal blood pool]. 177Lu-FAP-2286 was administered intravenously every 6 weeks for ≤6 cycles. The primary endpoint was dosage-limiting toxicities (DLT) and treatment-emergent adverse events (TEAE). RESULTS: Of 35 patients imaged with 68Ga-FAP-2286, 27 received 177Lu-FAP-2286 (3.70 GBq, n = 3; 5.55 GBq, n = 6; 7.40 GBq, n = 7; 9.25 GBq, n = 11). Two DLTs were observed: one patient who received 5.55 GBq of 177Lu-FAP-2286 experienced grade 4 lymphopenia, and one patient who received 9.25 GBq experienced grade 3 hemoptysis; these were the only treatment-related grade ≥3 TEAEs. All-cause grade ≥3 TEAEs were reported for 11 patients (40.7%). The RP2D for 177Lu-FAP-2286 monotherapy was determined to be 9.25 GBq. Preliminary Response Evaluation Criteria in Solid Tumors efficacy findings demonstrated a partial response in 1 patient and stable disease in 10 patients (maintained for at least two assessments in 6 patients). CONCLUSIONS: 177Lu-FAP-2286 was well tolerated in patients with advanced solid tumors. The safety and preliminary efficacy findings support its continued development in phase II.",
  "abstract_shown": true,
  "affiliations": [
    "The University of Alabama at Birmingham 1 Department of Radiology, , Birmingham, Alabama",
    "University of California San Francisco 2 Division of Hematology/Oncology, Department of Medicine, , San Francisco, California",
    "3Department of Radiology, University of Iowa, Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa",
    "The University of Texas MD Anderson Cancer Center 4 Department of Investigational Cancer Therapeutics, , Houston, Texas",
    "Mayo Clinic in Rochester 5 , Rochester, Minnesota",
    "Columbia University Irving Medical Center 6 Division of Hematology/Oncology, Department of Medicine, , New York, New York",
    "7Novartis Pharmaceuticals Corp., East Hanover, New Jersey",
    "8Advanced Accelerator Applications, a Novartis Company, Geneva, Switzerland",
    "9Novartis Biomedical Research, Basel, Switzerland",
    "10Novartis Pharmaceuticals UK Ltd, London, United Kingdom",
    "11Novartis Pharma AG, Basel, Switzerland",
    "University of California San Francisco 12 Department of Radiology and Biomedical Imaging, , San Francisco, California"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 12,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Jonathan McConathy",
      "orcid": "0000-0003-4681-2322"
    },
    {
      "affs": [
        1
      ],
      "name": "Vadim S. Koshkin",
      "orcid": "0000-0003-2277-8668"
    },
    {
      "affs": [
        2
      ],
      "name": "Yusuf Menda",
      "orcid": "0000-0001-7551-2789"
    },
    {
      "affs": [
        3
      ],
      "name": "Jordi Ahnert Rodon",
      "orcid": "0000-0001-6467-3632"
    },
    {
      "affs": [
        4
      ],
      "name": "Ajit Harishkumar Goenka",
      "orcid": "0000-0002-7804-2695"
    },
    {
      "affs": [
        5
      ],
      "name": "Ryan H. Moy",
      "orcid": "0000-0002-0507-8590"
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    {
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        6
      ],
      "name": "Sophie Morse",
      "orcid": "0009-0003-6504-9024"
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    {
      "affs": [
        7
      ],
      "name": "Arnaud Demange",
      "orcid": "0009-0001-3363-6051"
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    {
      "affs": [
        8
      ],
      "name": "Lars Blumenstein",
      "orcid": "0009-0004-6018-8049"
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    {
      "affs": [
        9
      ],
      "name": "Burcu Babaoğlan",
      "orcid": "0009-0007-7332-1613"
    },
    {
      "affs": [
        10
      ],
      "name": "Paola Aimone",
      "orcid": "0000-0001-8441-6203"
    },
    {
      "affs": [
        11
      ],
      "name": "Thomas A. Hope",
      "orcid": "0000-0002-2228-5823"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/dphs5s9zemct2.bib",
  "cited_by": 12,
  "doi": "10.1158/1078-0432.ccr-25-4356",
  "fulltext_url": null,
  "id": "dphs5s9zemct2",
  "issns": [
    "1078-0432",
    "1557-3265"
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  "landing_url": "https://doi.org/10.1158/1078-0432.ccr-25-4356",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
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      "2741|Radiopharmaceutical Chemistry and Applications"
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  "pdf_url": null,
  "pmcid": "PMC13335097",
  "pmid": "42223513",
  "published": "2026-06-01",
  "publisher": "American Association for Cancer Research",
  "ris": "https://research.draconitic.com/paper/dphs5s9zemct2.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T13:26:56Z",
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  "subjects": [
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      "field": "medicine",
      "origin": "openalex:2741|Radiopharmaceutical Chemistry and Applications",
      "subfield": "imaging"
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  ],
  "title": "Targeting Fibroblast Activation Protein with [177Lu]Lu-FAP-2286 in Patients with Advanced Solid Tumors in the Phase I LuMIERE Trial",
  "title_text": "Targeting Fibroblast Activation Protein with [177Lu]Lu-FAP-2286 in Patients with Advanced Solid Tumors in the Phase I LuMIERE Trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-06T13:20:39Z",
  "url": "https://research.draconitic.com/paper/dphs5s9zemct2",
  "venue": "Clinical Cancer Research",
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}