ArticleClinical cancer research : an official journal of the American Association for Cancer Research2026
Targeting Fibroblast Activation Protein with [177Lu]Lu-FAP-2286 in Patients with Advanced Solid Tumors in the Phase I LuMIERE Trial.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04939610 (LuMIERE), which is not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor
Who cites it
1 citing paper in PubMed.
- Fibroblast activation protein inhibitor radiotheranostics for imaging activated tumor stroma and guiding radionuclide therapy.Frontiers in oncology · 2026Review
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Authors and funding
12 authors.
Funding
Abstract
purposeFibroblast 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
methodsLuMIERE is a prospective, open-label, non-randomized, 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 (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 (DLTs) and treatment-emergent adverse events (TEAEs).
resultsOf 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 as 9.25 GBq. Preliminary RECIST efficacy findings demonstrated partial response in one patient and stable disease in 10 patients (maintained for at least two assessments in six patients).
conclusions177Lu-FAP-2286 was well tolerated in patients with advanced solid tumors. The safety and preliminary efficacy findings support its continued development in phase II.
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