Evidence map›Paper›PMID 41530380›Full record

ArticleNature medicine2026

Linavonkibart and pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors: a phase 1 trial.

Timothy A Yap, Randy F Sweis, Ulka Vaishampayan, Deepak Kilari, Justin F Gainor, Meredith McKean, Minal Barve, Ahmad A Tarhini, Bruno Bockorny, Guru Sonpavde and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Nature medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04291079 (A Phase 1, Open-Label, Dose-Escalation, and Dose-Expansion Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of SRK-181 Alone and in Combination With Anti-PD-), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT04291079 phase1completednot on this map

A Phase 1, Open-Label, Dose-Escalation, and Dose-Expansion Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of SRK-181 Alone and in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

TypeinterventionalSponsorScholar Rock, Inc.Ran2020 to 2025Enrolled112ConditionsCancerArmsSRK-181, anti-PD-(L)1 antibody therapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. 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.

Timothy A Yap *The University of Texas MD Anderson Cancer Center, Houston, TX, USA. TYap@mdanderson.org.ORCID http://orcid.org/0000-0002-2154-3309
Randy F Sweis *University of Chicago, Chicago, IL, USA.
Ulka VaishampayanUniversity of Michigan, Ann Arbor, MI, USA.
Deepak KilariMedical College of Wisconsin, Milwaukee, WI, USA.
Justin F GainorMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Meredith McKeanSarah Cannon Research Institute, Nashville, TN, USA.
Minal BarveSarah Cannon Research Institute at Mary Crowley, Dallas, TX, USA.
Ahmad A TarhiniH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.ORCID http://orcid.org/0000-0002-3193-9702
Bruno BockornyBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-9162-1560
Guru SonpavdeAdventHealth Medical Group, Orlando, FL, USA.ORCID http://orcid.org/0000-0002-1010-9611
David ParkSt. Jude Crosson Cancer Institute/Providence Medical Foundation, Fullerton, CA, USA.
Sunil BabuFort Wayne Medical Oncology and Hematology, Fort Wayne, IN, USA.
Yawen JuScholar Rock, Inc., Cambridge, MA, USA.
Lan LiuScholar Rock, Inc., Cambridge, MA, USA.
Susan HenryScholar Rock, Inc., Cambridge, MA, USA.
Giridhar S TirucheraiScholar Rock, Inc., Cambridge, MA, USA.
Stephen DeWallScholar Rock, Inc., Cambridge, MA, USA.ORCID http://orcid.org/0000-0002-8119-5748
Mohammed QatananiScholar Rock, Inc., Cambridge, MA, USA.
Jing L MarantzScholar Rock, Inc., Cambridge, MA, USA.
Lu GanScholar Rock, Inc., Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although immune checkpoint inhibitor therapies have revolutionized oncology, many cancers are unresponsive or develop resistance that involves transforming growth factor-β1 (TGFβ1). This multicenter, open-label, phase 1 study (DRAGON trial, SRK-181-001) evaluated safety, pharmacokinetics, pharmacodynamics, predictive biomarkers and efficacy of linavonkibart, a first-in-class fully human selective anti-latent TGFβ1 antibody with anti-programmed cell death protein 1 (PD-1) therapy. The DRAGON trial was divided into three treatment parts: part A1 (dose-escalation cohorts with single-agent linavonkibart), part A2 (dose-escalation cohorts with the combination treatment of linavonkibart and pembrolizumab) and part B (dose-expansion cohorts with the combination treatment). The primary objective of the study was to determine the safety and tolerability of linavonkibart alone and in combination with pembrolizumab. Secondary objectives included evaluation of linavonkibart pharmacokinetics for each treatment paradigm, assessment of anti-linavonkibart antibody development (parts A and B) and measurement of antitumor activity (part B) after treatment. All primary and secondary objectives were met in the study. Overall, linavonkibart had a manageable safety profile, and combined therapy with pembrolizumab was generally consistent with that of pembrolizumab monotherapy. Dermatological reactions were the only additional risk identified. Neither cytokine release syndrome nor infusion interruption was observed in any patient enrolled in DRAGON. In part A (n = 34), no dose-limiting toxicities or grade 4 or 5 treatment-related adverse events occurred (linavonkibart; ≤3,000 mg once every 3 weeks (Q3W) and 2,000 mg once every 2 weeks (Q2W)). In part B (n = 78), patients progressing on prior anti-PD-1 therapy received linavonkibart (1,500 mg Q3W/1,000 mg Q2W) with pembrolizumab (200 mg Q3W). This combination demonstrated confirmed objective response rates of 20.0%, 18.2%, 9.1% and 9.1% in anti-PD-1-resistant patients with clear cell renal cell cancer (ccRCC), melanoma, head and neck squamous cell cancer and urothelial cancer, respectively. Biomarker data provide proof of mechanism and a potential ccRCC patient selection strategy. ClinicalTrials.gov identifier: NCT04291079 .

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmImmune Checkpoint InhibitorsNeoplasmsAdultAgedFemaleHumansMaleMiddle AgedProgrammed Cell Death 1 ReceptorTransforming Growth Factor beta1Antibodies, Monoclonal, HumanizedcamrelizumabImmune Checkpoint InhibitorspembrolizumabProgrammed Cell Death 1 ReceptorSRK-181Transforming Growth Factor beta1

Identifiers

PMID41530380
PMCPMC13004668

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.