Evidence map›Paper›PMID 38750034›Full record

ArticleNature communications2024

CEA-CD3 bispecific antibody cibisatamab with or without atezolizumab in patients with CEA-positive solid tumours: results of two multi-institutional Phase 1 trials.

Neil H Segal, Ignacio Melero, Victor Moreno, Neeltje Steeghs, Aurelien Marabelle, Kristoffer Rohrberg, Maria E Rodriguez-Ruiz, Joseph P Eder, Cathy Eng, Gulam A Manji and 14 more

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing 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.

NCT02324257 phase1completednot on this map

An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688, A Novel T-cell Bispecific Antibody That Targets the Human Carcinoembryonic Antigen (CEA) on Tumor Cells and CD3 on T Cells, Administered Intravenously in Patients With Locally Advanced and/or Metastatic CEA(+) Solid Tumors

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2019Enrolled149ConditionsSolid TumorsArmsRO6958688, Obinutuzumab, Tocilizumab
NCT02650713 phase1completednot on this map

An Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors

TypeinterventionalSponsorHoffmann-La RocheRan2016 to 2020Enrolled228ConditionsSolid TumorsArmsAtezolizumab, RO6958688
3 · Its place in the literature

Who cites it

54 citing papers in PubMed.

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  18. Cergutuzumab Amunaleukin in Combination with Atezolizumab in Patients with Carcinoembryonic Antigen-Positive Advanced/Metastatic Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
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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

24 authors.

Neil H SegalMemorial Sloan Kettering Cancer Center, New York, NY, United States; Weill Cornell Medical College, New York, NY, USA. segaln@mskcc.org.ORCID http://orcid.org/0000-0002-3047-2303
Ignacio MeleroClínica Universidad de Navarra and CIMA University of Navarra, Navarra, Spain.ORCID http://orcid.org/0000-0002-1360-348X
Victor MorenoHospital Fundación Jiménez Díaz, Madrid, Spain.ORCID http://orcid.org/0000-0001-6099-4236
Neeltje SteeghsNetherlands Cancer Institute, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-2989-2279
Aurelien MarabelleGustave Roussy, Université Paris-Saclay, Villejuif, France.ORCID http://orcid.org/0000-0002-5816-3019
Kristoffer RohrbergCopenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.ORCID http://orcid.org/0000-0002-5448-9003
Maria E Rodriguez-RuizClínica Universidad de Navarra and CIMA University of Navarra, Navarra, Spain.
Joseph P EderYale University Cancer Center, New Haven, CT, USA.
Cathy EngVanderbilt Ingram Cancer Center, Nashville, TN, USA.
Gulam A ManjiColumbia University, New York, NY, USA.
Daniel WaterkampGenentech, Inc., South San Francisco, CA, USA.
Barbara LeutgebF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Said BouseidaF. Hoffmann-La Roche, Ltd, Basel, Switzerland.ORCID http://orcid.org/0000-0003-3908-4646
Nick FlinnF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Meghna Das ThakurGenentech, Inc., South San Francisco, CA, USA.
Markus C ElzeF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Hartmut KoeppenGenentech, Inc., South San Francisco, CA, USA.
Candice JamoisF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Meret Martin-FacklamF. Hoffmann-La Roche, Ltd, Basel, Switzerland.
Christopher H LieuUniversity of Colorado, Aurora, Denver, CO, USA.ORCID http://orcid.org/0000-0002-4852-4642
Emiliano CalvoSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.ORCID http://orcid.org/0000-0003-4921-829X
Luis Paz-AresUniversity Hospital 12 de Octubre, Madrid, Spain.
Josep TaberneroVall d'Hebron Hospital Campus and Institute of Oncology (VHIO), Barcelona, Spain.ORCID http://orcid.org/0000-0002-2495-8139
Guillem ArgilésVall d'Hebron Hospital Campus and Institute of Oncology (VHIO), Barcelona, Spain.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Cibisatamab is a bispecific antibody-based construct targeting carcinoembryonic antigen (CEA) on tumour cells and CD3 epsilon chain as a T-cell engager. Here we evaluated cibisatamab for advanced CEA-positive solid tumours in two open-label Phase 1 dose-escalation and -expansion studies: as a single agent with or without obinutuzumab in S1 (NCT02324257) and with atezolizumab in S2 (NCT02650713). Primary endpoints were safety, dose finding, and pharmacokinetics in S1; safety and dose finding in S2. Secondary endpoints were anti-tumour activity (including overall response rate, ORR) and pharmacodynamics in S1; anti-tumour activity, pharmacodynamics and pharmacokinetics in S2. S1 and S2 enrolled a total of 149 and 228 patients, respectively. Grade ≥3 cibisatamab-related adverse events occurred in 36% of S1 and 49% of S2 patients. The ORR was 4% in S1 and 7% in S2. In S2, patients with microsatellite stable colorectal carcinoma (MSS-CRC) given flat doses of cibisatamab and atezolizumab demonstrated an ORR of 14%. In S1 and S2, 40% and 52% of patients, respectively, developed persistent anti-drug antibodies (ADAs). ADA appearance could be mitigated by obinutuzumab-pretreatment, with 8% of patients having persistent ADAs. Overall, cibisatamab warrants further exploration in immunotherapy combination strategies for MSS-CRC.

Indexed as

Antibodies, BispecificAntibodies, Monoclonal, HumanizedCarcinoembryonic AntigenCD3 ComplexNeoplasmsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedAntibodies, BispecificAntibodies, Monoclonal, HumanizedCarcinoembryonic AntigenCD3 Complex

Identifiers

PMID38750034
PMCPMC11096172

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.