Evidence map›Paper›PMID 42010119›Full record

ArticleNature medicine2026

Cibisatamab and FAP-4-1BBL in microsatellite-stable colorectal cancer: a phase 1b trial.

Ignacio Melero, Tamara Tanos, Emiliano Calvo Aller, Camilla Qvortrup, Marloes van Dongen, Iosune Baraibar, Seung-Hoon Beom, Fiona Thistlethwaite, Maria Del Carmen Riesco, Maria Martinez Garcia and 12 more

Abstract readClinical Trial, Phase I
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. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. 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

22 authors.

Ignacio Melero *Clínica Universidad de Navarra, CIMA and CIBERONC, Pamplona, Spain.ORCID http://orcid.org/0000-0002-1360-348X
Tamara Tanos *Roche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Emiliano Calvo AllerSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.ORCID http://orcid.org/0000-0003-4921-829X
Camilla QvortrupDepartment of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Marloes van DongenNetherlands Cancer Institute Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Iosune BaraibarVall d'Hebron Hospital Campus and Institute of Oncology (VHIO), CIBERONC, IR-HUVH, Barcelona, Spain.ORCID http://orcid.org/0000-0002-3500-9641
Seung-Hoon BeomYonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Fiona ThistlethwaiteThe Christie NHS Foundation Trust and University of Manchester, Manchester, UK.ORCID http://orcid.org/0000-0002-4832-7008
Maria Del Carmen RiescoMedical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain.
Maria Martinez GarciaMedical Oncology Department, Hospital del Mar Research Institute, Barcelona, Spain.ORCID http://orcid.org/0000-0001-5891-3935
Victoria WoodcockOxford University Hospitals NHS Foundation Trust, Oxford, UK.ORCID http://orcid.org/0000-0001-7656-728X
Tae Won KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-9522-1997
Pablo UmanaPharma Research & Early Development, Roche Innovation Center Zurich, Zurich, Switzerland.
Christine McIntyreRoche Pharma Research & Early Development, Roche Innovation Center Welwyn, Welwyn Garden City, UK.
Lining ChenRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Christian HeichingerRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.ORCID http://orcid.org/0009-0000-2191-3093
Heather HintonRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Tulun SaylanRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Iakov I DavydovComputational Sciences Center of Excellence, Roche Innovation Center Basel, Basel, Switzerland.ORCID http://orcid.org/0000-0003-3510-3926
Ernesto GuarinRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Axel BoehnkeRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland. axel.boehnke@roche.com.ORCID http://orcid.org/0009-0008-3225-2428
Victor MorenoSTART Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain.ORCID http://orcid.org/0000-0001-6099-4236

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluated cibisatamab, a carcinoembryonic antigen (CEA)-directed CD3 T cell-engaging bispecific antibody, in combination with FAP-4-1BBL, a fibroblast activation protein (FAP)-targeted 4-1BB ligand providing tumor-localized co-stimulation, in an open-label phase 1b dose-escalation study in patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) progressing after two or more prior therapies. Patients received cibisatamab with escalating doses of FAP-4-1BBL weekly or every 3 weeks after obinutuzumab pretreatment to mitigate anti-drug antibody formation. The primary endpoint was safety; secondary endpoints included antitumor activity, pharmacokinetics and biomarker analyses. Among 52 treated patients, the combination showed a manageable safety profile. Dose-limiting toxicities occurred in 2 out of 52 patients (3.8%). Cytokine release syndrome (CRS) occurred in 30 out of 52 patients (57.7%; grade ≥3: 2 out of 52, 3.8%) and was manageable; after a cycle 1 cibisatamab dose reduction to 60 mg, serious CRS occurred in 4 out of 27 patients (14.8%; grade ≥3: 0 out of 27). Gastrointestinal toxicities consistent with CEA-directed T cell engagement were observed. Colitis occurred in 7 out of 52 patients (13.5%), including immune-mediated enterocolitis and one fatal cytomegalovirus colitis. No maximum tolerated dose of FAP-4-1BBL was established. Confirmed partial responses were observed in 7 out of 52 patients (13.5%). Pharmacodynamic analyses demonstrated systemic immune activation, including increased IFNγ, soluble CD25, soluble 4-1BB (CD137) and activated, proliferating CD8

Indexed as

Antibodies, BispecificColorectal NeoplasmsAdultAgedCarcinoembryonic AntigenEndopeptidasesFemaleFibroblast Activation Protein AlphaGelatinasesHumansMaleMembrane ProteinsMiddle AgedSerine EndopeptidasesAntibodies, BispecificCarcinoembryonic AntigenEndopeptidasesFibroblast Activation Protein AlphaGelatinasesMembrane ProteinsSerine Endopeptidases

Identifiers

PMID42010119
PMCPMC13375537

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.