Evidence map›Paper›PMID 27507056›Full record

ArticleOncotarget2016

First-in-human phase I clinical trial of RG7356, an anti-CD44 humanized antibody, in patients with advanced, CD44-expressing solid tumors.

C Willemien Menke-van der Houven van Oordt, Carlos Gomez-Roca, Carla van Herpen, Andrew L Coveler, Devalingam Mahalingam, Henk M W Verheul, Winette T A van der Graaf, Randolph Christen, Dominik Rüttinger, Stefan Weigand and 8 more

Open access · diamondAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed
4.9field-weighted citation impact, top 5% of its field
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

98 citing papers in PubMed, 151 citations in OpenAlex.

  1. Encoding Cell-Surface Receptor Function Through Glycosylation: Lessons From CD44.Chembiochem : a European journal of chemical biology · 2026
    Review
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  8. Amoeboid cancer cells at a glance.Journal of cell science · 2026
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  20. Understanding and overcoming multidrug resistance in cancer.Nature reviews. Clinical oncology · 2025
    Review

38 more citing papers are in PubMed but not listed here.

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

18 authors at 10 institutions in 6 countries.

C Willemien Menke-van der Houven van OordtDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Carlos Gomez-RocaClinical Research Unit, Department of Medical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, France.
Carla van HerpenRadboud University Medical Center, Nijmegen, The Netherlands.
Andrew L CovelerDepartment of Medicine, Division of Oncology, University of Washington, Seattle, WA, USA.
Devalingam MahalingamCancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, TX, USA.
Henk M W VerheulDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Winette T A van der GraafRadboud University Medical Center, Nijmegen, The Netherlands.
Randolph ChristenProduct Development, Safety Risk Management, Roche, Basel, Switzerland.
Dominik RüttingerPharma Research & Early Development, Roche Innovation Center, Penzberg, Germany.
Stefan WeigandPharma Research & Early Development, Roche Innovation Center, Penzberg, Germany.
Michael A CannarilePharma Research & Early Development, Roche Innovation Center, Penzberg, Germany.
Florian HeilPharma Research & Early Development, Roche Innovation Center, Penzberg, Germany.
Michael BrewsterPharma Research & Early Development, Roche Innovation Centre, Welwyn, UK.
Antje-Christine WalzPharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Tapan K NayakPharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Ernesto GuarinPharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Valerie MeressePharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Christophe Le TourneauDepartment of Medical Oncology, Institut Curie, Saint-Cloud & Paris, France.
Roche Pharma AG (Germany) · DERoche (Switzerland) · CHAmsterdam UMC Location VUmc · NLRadboud University Nijmegen · NLInstitut Claudius Regaud · FRInstitut Curie · FRRadboud University Medical Center · NLRoche (United Kingdom) · GBThe University of Texas Health Science Center at San Antonio · USUniversité de Versailles Saint-Quentin-en-Yvelines · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Transmembrane glycoprotein CD44 is overexpressed in various malignancies. Interactions between CD44 and hyaluronic acid are associated with poor prognosis, making CD44 an attractive therapeutic target. We report results from a first-in-human phase I trial of RG7356, a recombinant anti-CD44 immunoglobulin G1 humanized monoclonal antibody, in patients with advanced CD44-expressing solid malignancies.Sixty-five heavily pretreated patients not amenable to standard therapy were enrolled and received RG7356 intravenously biweekly (q2w) or weekly (qw) in escalating doses from 100 mg to 2,250 mg. RG7356 was well tolerated. Most frequent adverse events were fever, headache and fatigue. Dose-limiting toxicities included headache (1,500 mg q2w and 1,350 mg qw) and febrile neutropenia (2,250 mg q2w). The maximum tolerated dose with q2w dosing was 1,500 mg, but was not defined for qw dosing due to early study termination. Clinical efficacy was modest; 13/61 patients (21%) experienced disease stabilization lasting a median of 12 (range, 6-35) weeks. No apparent dose- or dose schedule-dependent changes in biological activity were reported from blood or tissue analyses. Tumor-targeting by positron emission tomography (PET) using 89Zr-labeled RG7356 was observed for doses ≥200 mg (q2w) warranting further investigation of this agent in combination regimens.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalDisease ProgressionFemaleHumansHyaluronan ReceptorsMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPilot ProjectsPositron-Emission TomographyRadiopharmaceuticalsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCD44 protein, humanHyaluronan ReceptorsRadiopharmaceuticalsRG7356Zirconiumadvanced CD44-expressing solid malignanciesadvanced solid tumorsanti-CD44 humanized antibodyphase I trialRG7356

Identifiers

PMID27507056
PMCPMC5346770
OpenAlexW2486571534

What OpenQuestion holds

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Registered trials

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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.