Evidence map›Paper›PMID 37537253›Full record

Trial reportBritish journal of cancer2023

A Phase Ib/II study of IGF-neutralising antibody xentuzumab with enzalutamide in metastatic castration-resistant prostate cancer.

Valentine M Macaulay, Simon Lord, Syed Hussain, José Pablo Maroto, Robert Hugh Jones, Miguel Ángel Climent, Natalie Cook, Chia-Chi Lin, Shian-Shiang Wang, Diletta Bianchini and 4 more

Open access · hybridAbstract readMulticenter StudyClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 18% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. IGF-1R targeting in cancer - does sub-cellular localization matter?Journal of experimental & clinical cancer research : CR · 2023
    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

14 authors at 12 institutions in 5 countries.

Valentine M MacaulayNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-8659-0192
Simon LordDepartment of Oncology, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-7946-5609
Syed HussainDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0003-1552-511X
José Pablo MarotoHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Robert Hugh JonesVelindre Cancer Centre and Cardiff University, Cardiff, UK.
Miguel Ángel ClimentInstituto Valenciano de Oncología (IVO), Valencia, Spain.
Natalie CookThe Christie NHS Foundation Trust and the University of Manchester, Manchester, UK.ORCID http://orcid.org/0000-0003-2606-1082
Chia-Chi LinNational Taiwan University Hospital, Taipei, Taiwan.
Shian-Shiang WangTaichung Veterans General Hospital, Taichung, Taiwan.
Diletta BianchiniThe Institute of Cancer Research, London, UK.
Mark BaileyBoehringer Ingelheim Ltd, Bracknell, Berkshire, UK.
Laura SchliekerExternal Statistician on behalf of Boehringer Ingelheim GmbH & Co. KG, Staburo GmbH & Co. KG, Munich, Germany.
Thomas BogenriederBoehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria.
Johann de BonoThe Institute of Cancer Research, London, UK. jdebono@icr.ac.uk.
Royal Marsden NHS Foundation Trust · GBUniversity of Oxford · GBBoehringer Ingelheim (Austria) · ATBoehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United Kingdom) · GBFundación Instituto Valenciano de Oncología · ESHospital de Sant Pau · ESNational Taiwan University Hospital · TWTaichung Veterans General Hospital · TWUniversity of Manchester · GBUniversity of Sheffield · GBVelindre Cancer Centre · GB

Funding

Cancer Research UK 27060Medical Research Council MR/W018217/1
6 · The paper itself

Abstract

backgroundThis multicentre, open-label, Phase Ib/II trial evaluated the insulin-like growth factor (IGF) 1/2 neutralising antibody xentuzumab plus enzalutamide in metastatic castrate-resistant prostate cancer (mCRPC).

methodsThe trial included Phase Ib escalation and expansion parts and a randomised Phase II part versus enzalutamide alone. Primary endpoints in the Phase Ib escalation, Phase Ib expansion and Phase II parts were maximum tolerated dose (MTD), prostate-specific antigen response and investigator-assessed progression-free survival (PFS), respectively. Patients in the Phase Ib escalation and Phase II parts had progressed on/after docetaxel/abiraterone.

resultsIn the Phase Ib escalation (n = 10), no dose-limiting toxicities were reported, and xentuzumab 1000 mg weekly plus enzalutamide 160 mg daily (Xe1000 + En160) was defined as the MTD and recommended Phase 2 dose. In the Phase Ib expansion (n = 24), median PFS was 8.2 months, and one patient had a confirmed, long-term response. In Phase II (n = 86), median PFS for the Xe1000 + En160 and En160 arms was 7.4 and 6.2 months, respectively. Subgroup analysis suggested trends towards benefit with Xe1000 + En160 in patients whose tumours had high levels of IGF1 mRNA or PTEN protein. Overall, the combination was well tolerated.

conclusionsXentuzumab plus enzalutamide was tolerable but lacked antitumour activity in unselected patients with mCRPC. CLINICAL

trial registrationEudraCT number 2013-004011-41.

Indexed as

Prostatic Neoplasms, Castration-ResistantAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntineoplastic Combined Chemotherapy ProtocolsBenzamidesHumansMaleNitrilesPhenylthiohydantoinTreatment OutcomeAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingBenzamidesenzalutamideNitrilesPhenylthiohydantoinxentuzumab

Identifiers

PMID37537253
PMCPMC10491782
OpenAlexW4385515699

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.