Evidence mapPaperPMID 42223513Full record

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.

Jonathan McConathy, Vadim S Koshkin, Yusuf Menda, Jordi Rodon, Ajit H Goenka, Ryan H Moy, Sophie Morse, Arnaud Demange, Lars Blumenstein, Burcu Babaoglan and 2 more

Registry-linked trialAbstract read
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

NCT04939610 phase1 / phase2recruitingnot on this map

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

TypeinterventionalSponsorNovartis PharmaceuticalsRan2021 to 2028Enrolled222ConditionsSolid TumorArms68Ga-FAP-2286, 177Lu-FAP-2286
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jonathan McConathyUniversity of Alabama at Birmingham Birmingham United States.ORCID 0000-0003-4681-2322
Vadim S KoshkinUniversity of California, San Francisco San Francisco, CA United States.ORCID 0000-0003-2277-8668
Yusuf MendaUniversity of Iowa Hospitals and Clinics United States.ORCID 0000-0001-7551-2789
Jordi RodonThe University of Texas MD Anderson Cancer Center Houston, Texas United States.ORCID 0000-0001-6467-3632
Ajit H GoenkaMayo Clinic Rochester, Minnesota United States.ORCID 0000-0002-7804-2695
Ryan H MoyColumbia University Medical Center New York, NY United States.ORCID 0000-0002-0507-8590
Sophie MorseNovartis Pharmaceuticals Corp., East Hanover, New Jersey United States.ORCID 0009-0003-6504-9024
Arnaud DemangeAdvanced Accelerator Applications, a Novartis Company, Geneva, Switzerland Switzerland.ORCID 0009-0001-3363-6051
Lars BlumensteinNovartis Biomedical Research, Basel, Switzerland Switzerland.ORCID 0009-0004-6018-8049
Burcu BabaoglanNovartis Pharmaceuticals UK Ltd, London, UK United Kingdom.ORCID 0009-0007-7332-1613
Paola AimoneNovartis Foundation Switzerland.ORCID 0000-0001-8441-6203
Thomas A HopeUniversity of California, San Francisco San Francisco, CA United States.ORCID 0000-0002-2228-5823

Funding

Transgenic and Knockout Shared ResourceP30CA015083 · MAYO CLINIC ROCHESTER · 1985 to 2025
$27.9M
Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)R01CA272628 · MAYO CLINIC ROCHESTER · 2025 to 2025
$955k
Optimizing Pancreatic Cancer Management with Next Generation Imaging and Liquid BiopsyR01CA256969 · FRED HUTCHINSON CANCER CENTER · 2025 to 2025
$0k
NCI NIH HHS P30 CA015083NCI NIH HHS R01 CA256969NCI NIH HHS R01 CA272628
6 · The paper itself

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.

Identifiers

PMID42223513
PMCPMC13335097

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.