Evidence map›Paper›PMID 40631774›Full record

ArticleThe oncologist2025

First-in-human phase I open-label study of the LAG-3 antagonist antibody INCAGN02385 in patients with select advanced or metastatic solid tumors.

John D Powderly, Martin E Gutierrez, Ani S Balmanoukian, Paul E Hoyle, Zhiwan Dong, Lulu Cheng, Xuejun Chen, John E Janik, Nawel Bourayou, Omid Hamid

Abstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

10 authors.

John D PowderlyCarolina BioOncology Institute, Huntersville, NC 28078, United States.ORCID 0000-0002-7608-0380
Martin E GutierrezHackensack University Medical Center, Hackensack, NJ 07601, United States.
Ani S BalmanoukianThe Angeles Clinic and Research Institute, a Cedars Sinai Affiliate, Los Angeles, CA 90025, United States.
Paul E HoyleIncyte Corporation, Wilmington, DE 19803, United States.
Zhiwan DongIncyte Corporation, Wilmington, DE 19803, United States.
Lulu ChengIncyte Corporation, Wilmington, DE 19803, United States.
Xuejun ChenIncyte Corporation, Wilmington, DE 19803, United States.
John E JanikIncyte Corporation, Wilmington, DE 19803, United States.
Nawel BourayouIncyte Biosciences International Sàrl, 1110 Morges, Switzerland.
Omid HamidThe Angeles Clinic and Research Institute, a Cedars Sinai Affiliate, Los Angeles, CA 90025, United States.ORCID 0000-0002-8238-4655

Funding

Incyte Corporation
6 · The paper itself

Abstract

backgroundImmune checkpoint receptor lymphocyte-activation gene 3 (LAG-3) is an activation marker for CD4+ and CD8+ T cells. Prolonged LAG-3 expression downregulates T-cell activation; therefore, LAG-3 blockade may restore antitumor immune response. INCAGN02385 is a humanized monoclonal LAG-3-targeting antibody. This first-in-human phase I study evaluated INCAGN02385 for advanced/metastatic solid tumors. MATERIALS AND

methodsIn this dose escalation study, patients with select immunogenic advanced or metastatic solid tumors received a single INCAGN02385 infusion (25 mg to 750 mg) every 2 weeks (Q2W). Objectives included evaluation of safety/tolerability, maximum tolerated dose (MTD) (primary), pharmacokinetics (PK), antitumor activity (secondary).

resultsTwenty-two patients were enrolled and treated. Sixty-four percent had received ≥ 3 lines of systemic therapy. Sixty-eight percent had received prior immune checkpoint inhibitor (ICI) therapy; anti-programmed death protein-1/anti-programmed death ligand-1, 68%, anti-cytotoxic T-lymphocyte-associated protein-4 therapy, 18%. No dose-limiting toxicities occurred, and an MTD was not reached. Sixteen patients (73%) experienced treatment-related adverse events (TRAEs), most frequently fatigue (n = 7). Except for one grade 3 lymphopenia TRAE, all were grade 1/2 severity. Two patients experienced sponsor-assessed immune-related AEs (pneumonitis, peripheral sensory neuropathy [n = 1] patient each). INCAGN02385 PK parameters were dose proportional across all doses evaluated. Six patients achieved stable disease lasting ≥ 56 days (range, 57-413 days).

conclusionsINCAGN02385 exhibited linear PK and preliminary evidence of disease control in this heavily pretreated population, consistent with other LAG-3-targeting monotherapies. A 350-mg Q2W dose was selected for phase II studies that will focus on combinations of INCAGN02385 with other ICIs.

Indexed as

Antibodies, Monoclonal, HumanizedAntigens, CDNeoplasmsAdultAgedFemaleHumansLymphocyte Activation Gene 3 ProteinMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisAntibodies, Monoclonal, HumanizedAntigens, CDLag3 protein, humanLymphocyte Activation Gene 3 Proteincarcinomaclinical trial phase Iimmune checkpoint inhibitorsimmunotherapymetastasesmonoclonal antibodies

Identifiers

PMID40631774
PMCPMC12238943

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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 OpenQuestion graph.