Evidence map›Paper›PMID 40016550›Full record

ArticleBJC reports2025

CITRINO: phase 1 dose escalation study of anti-LAG-3 antibody encelimab alone or in combination with anti-PD-1 dostarlimab in patients with advanced/metastatic solid tumours.

J Randolph Hecht, Jean-Marie Michot, David Bajor, Amita Patnaik, Ki Y Chung, Judy Wang, Gerald Falchook, James M Cleary, Richard Kim, Anuradha Krishnamurthy and 10 more

Registry-linked trialAbstract read
In one paragraph

Article in BJC reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03250832 (A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03250832 phase1completednot on this map

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors

TypeinterventionalSponsorTesaro, Inc.Ran2017 to 2023Enrolled111ConditionsNeoplasmsArmsTSR-033, Dostarlimab, mFOLFOX6, FOLFIRI, Bevacizumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Therapeutic potential of targeting LAG-3 in cancer.Journal for immunotherapy of cancer · 2025
    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

20 authors.

J Randolph HechtDavid Geffen School of Medicine, University of California Los Angeles (UCLA), Los Angeles, CA, USA. jrhecht@mednet.ucla.edu.
Jean-Marie MichotDépartement d'Innovation Thérapeutique et d'Essais Précoces, Institut de Cancérologie Gustave Roussy, Villejuif, France.
David BajorDepartment of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Amita PatnaikSTART San Antonio, San Antonio, TX, USA.
Ki Y ChungDepartment of Medicine, Prisma Health Cancer Institute, Greenville, SC, USA.
Judy WangDrug Development Unit, Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA.
Gerald FalchookDrug Development Unit, Sarah Cannon Research Institute at HealthONE, Denver, CO, USA.
James M ClearyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Richard KimDepartment of Medical Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Anuradha KrishnamurthyDepartment of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Omkar MaratheThe Oncology Institute of Hope and Innovation, Whittier, CA, USA.
Hagop YoussoufianOncology Clinical Development, GSK, Waltham, MA, USA.
Catherine EllisOncology Clinical Development, GSK, Collegeville, PA, USA.
Angela WaszakOncology Clinical Development, GSK, Waltham, MA, USA.
Srimoyee GhoshOncology Clinical Development, GSK, Waltham, MA, USA.
Hailei ZhangOncology Clinical Development, GSK, Waltham, MA, USA.
Kaitlin YablonskiOncology Clinical Development, GSK, Collegeville, PA, USA.
Shruti D ShahOncology Clinical Development, GSK, Waltham, MA, USA.
Ivan Diaz-PadillaOncology Clinical Development, GSK, Zug, Switzerland.
Susanna UlahannanStephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDual programmed cell death protein (ligand)-1 (PD-[L]1) and lymphocyte-activation gene-3 (LAG-3) blockade has demonstrated improved anti-tumour response in some advanced solid tumours. CITRINO, a two-part, Phase 1 dose-escalation study, evaluated encelimab (TSR-033; novel anti-LAG-3) monotherapy and in combination in patients with advanced/metastatic solid tumours.

methodsPart 1 (P1) involved dose escalation (20-720 mg Q2W) of encelimab as monotherapy (P1A/B) and with dostarlimab (500 mg Q3W) in patients with previously treated advanced/metastatic solid tumours (P1C). P2 involved cohort expansion in patients with anti-PD-(L)1-naïve microsatellite stable advanced/metastatic colorectal cancer with recommended phase 2 dose (RP2D) of encelimab with dostarlimab as third/fourth-line therapy (P2A), or with dostarlimab, bevacizumab and mFOLFOX6/FOLFIRI as second-line therapy (P2B). Objectives included RP2D, safety/tolerability, efficacy, pharmacokinetics/pharmacodynamics, and exploratory biomarkers.

resultsMaximum tolerated encelimab dose was not reached; 720 mg Q2W was used for P2 plus dostarlimab 1000 mg Q6W. One dose-limiting toxicity occurred (Grade 2 myasthenia gravis; P1A). No clinical responses were observed in P1; 1 (3%) and 4 (17%) patients achieved partial response in P2A and 2B, respectively.

conclusionsEncelimab has a manageable safety profile as a monotherapy and in tested combinations; however, anti-tumour activity was limited. CLINICAL

trial registrationNCT03250832.

Identifiers

PMID40016550
PMCPMC11868598

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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 OpenQuestion graph.