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Last update 02 Apr 2026
Xentuzumab
Last update 02 Apr 2026
Overview
Basic Info
Drug Type Bispecific antibody |
Synonyms BI-836845 |
Target |
Action inhibitors |
Mechanism IGF-1 inhibitors(Insulin-like growth factor I inhibitors), IGF-2 inhibitors(Insulin-like growth factor II inhibitors) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 1 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 164717H
Source: *****
Sequence Code 164724L
Source: *****
Related
9
Clinical Trials associated with XentuzumabNCT05110495
Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN)
NCT03659136
XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
NCT03099174
An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.
100 Clinical Results associated with Xentuzumab
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100 Translational Medicine associated with Xentuzumab
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100 Patents (Medical) associated with Xentuzumab
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19
Literatures (Medical) associated with Xentuzumab01 Dec 2025BREAST
Artificial intelligence and radiomics biomarkers for treatment response prediction in advanced HER2-negative breast cancer
Article
Author: Schwartz, Lawrence H ; Schmitt, Julia ; Zhao, Binsheng ; Dercle, Laurent ; Amend, Mario ; McGale, Jeremy ; Peltzer, Alexander
STUDY AIM:
Despite the development of novel therapies, breast cancer mortality remains high. Improved treatment response assessment tools are needed. We aimed to test the transferability of externally validated AI/radiomics biomarkers for predicting treatment response in advanced, hormone receptor-positive (HR+), HER2-breast cancer treated with xentuzumab, exemestane, and everolimus.
METHODS:
Patient data from a phase Ib/II trial (May 2014-October 2016) were analyzed retrospectively. Eight imaging biomarkers (liver and overall tumor volume, two radiomics features representing tumor heterogeneity at both baseline and week 8) were validated for predicting clinical benefit using AUC analysis. An ancillary AI analysis developed a signature for predicting best overall response using 40 variables (3 clinical and 37 imaging) in the same cohort.
RESULTS:
Of 106 patients with data available for analysis, 28 had no clinical benefit from treatment (Group A) vs. 78 with clinical benefit (Group B). Seven of eight imaging biomarkers demonstrated significant predictive value. Participants in Group B exhibited significantly lower baseline and follow-up measures of liver and overall tumor volume, alongside marked changes in tumor heterogeneity by week 8. In our ancillary AI/radiomics model, the dominant drivers of prediction were changes in both liver tumor and overall tumor volume during treatment and the number of osteoblastic lesions on baseline bone scans.
CONCLUSION:
This cross-cancer proof-of-concept testing study supports the feasibility of applying multimodal AI/radiomics biomarkers to predict treatment response in advanced HR+, HER2- breast cancer, laying the foundation for broader pancancer and pantreatment applications pending further validation.
CLINICAL TRIAL REGISTRATION NUMBER:
NCT02123823.
01 Nov 2025ESMO Open
Phase Ib study of xentuzumab and abemaciclib in patients with advanced solid tumors and in combination with endocrine therapy in patients with advanced breast cancer
Article
Author: Oliveira, M. ; Yee, D. ; Puig, M. ; Gonçalves, A. ; Sablin, M.P. ; Vidal, M. ; Lorence, R.M. ; Fukuyama, Y. ; LoRusso, P. ; Forman, N. ; Stradella, A. ; Hardebeck, M.C. ; Iwata, H.
BACKGROUND:
This phase Ib trial assessed the insulin-like growth factor 1/2 neutralizing antibody, xentuzumab, plus abemaciclib ± endocrine therapy (ET) in patients with advanced/metastatic solid tumors, including hormone receptor (HR)-positive breast cancer.
PATIENTS AND METHODS:
In part 1, patients with advanced solid tumors received escalating doses of xentuzumab + abemaciclib (cohort A). In part 2, dose-finding cohorts B-D had advanced/metastatic HR-positive, human epidermal growth factor receptor 2-negative breast cancer and received xentuzumab + abemaciclib plus letrozole, anastrozole, or fulvestrant. Part 3 included expansion cohorts assessing xentuzumab + abemaciclib plus fulvestrant in patients with HR-positive, human epidermal growth factor receptor 2-negative breast cancer with visceral (cohort D1) or non-visceral disease (cohort D2) who had progressed following ET, or non-visceral disease who had progressed following ET and a cyclin-dependent kinase inhibitor (cohort F). Primary endpoints were maximum tolerated dose (cohorts A-D), 18-month progression-free survival (cohort D1/D2) and disease control (cohort F). Comprehensive biomarker analyses were undertaken.
RESULTS:
A total of 133 patients were treated. The maximum tolerated dose was xentuzumab 1000 mg once weekly plus abemaciclib 150 mg twice daily (cohorts A-D). The most common grade ≥3 adverse event was decreased neutrophil count. Cohorts B-D demonstrated response rates of ≥25%. The 18-month progression-free survival rate in cohorts D1/D2 was 41.4%/78.5%. The disease control rate in cohort F was 40.0%. Biomarker analysis indicated target engagement. Prognostic biomarkers included total serum insulin-like growth factor 1 concentrations, expression of CCND1, and MCL-1 mutations.
CONCLUSIONS:
Xentuzumab + abemaciclib + ETs demonstrated manageable tolerability and promising efficacy, especially in patients with breast cancer and non-visceral metastases.
05 Oct 2023British journal of cancer
A Phase Ib/II study of IGF-neutralising antibody xentuzumab with enzalutamide in metastatic castration-resistant prostate cancer
Article
Author: Schlieker, Laura ; Bianchini, Diletta ; Lin, Chia-Chi ; de Bono, Johann ; Maroto, José Pablo ; Lord, Simon ; Hussain, Syed ; Climent, Miguel Ángel ; Wang, Shian-Shiang ; Cook, Natalie ; Macaulay, Valentine M ; Bogenrieder, Thomas ; Bailey, Mark ; Jones, Robert Hugh
Abstract:
Background:
This 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).
Methods:
The 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.
Results:
In 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.
Conclusions:
Xentuzumab plus enzalutamide was tolerable but lacked antitumour activity in unselected patients with mCRPC.
Clinical trial registration:
EudraCT number 2013-004011-41.
100 Deals associated with Xentuzumab
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | United States | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Australia | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Belgium | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Canada | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | France | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Germany | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Greece | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Italy | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Portugal | 28 Nov 2018 | |
| Hormone receptor positive HER2 negative breast cancer | Phase 2 | Spain | 28 Nov 2018 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 1 | 120 | (Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide) | jsytmhcxto = wstcowwagi badhrfktjk (yompeeeaej, esmtjkxjzl - ayxyqizrvv) View more | - | 15 Jul 2025 | ||
(Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide) | jsytmhcxto = uydfqbyfec badhrfktjk (yompeeeaej, tflowsufwp - tulstlrwtg) View more | ||||||
Phase 1 | 164 | (Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II) | tfmgcsdzsv(mdvxmxiyju) = bqrcbzrrbu tpqytumubl (uhmxgmdkou, alduwzjblc - gnkhmxjpfz) View more | - | 15 Jul 2025 | ||
(Everolimus 10 mg + Exemestane 25 mg - Phase II) | tfmgcsdzsv(mdvxmxiyju) = qucnztbxky tpqytumubl (uhmxgmdkou, axkjtzjpvr - nsaakfirps) View more | ||||||
Phase 1 | 32 | (Xentuzumab + Afatinib 30 Milligram (mg) - Part A) | xvzogvwfip = lukytglznc fucupdxuqe (nisartenfq, ztkklekgwg - uekgpngett) | - | 25 Jun 2025 | ||
(Xentuzumab + Afatinib 40 mg - Part A) | xvzogvwfip = favyrdyivx fucupdxuqe (nisartenfq, nqwvbbeoqe - fpsnecdrju) | ||||||
Phase 1 | 133 | (Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib) | fqesftfpfo = nlhgsofern dpjqdjcvcd (oyhrhjohaf, zuoiplxqpm - bksmbdevtl) View more | - | 24 Jun 2025 | ||
(Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole) | fqesftfpfo = ptibdlqfll dpjqdjcvcd (oyhrhjohaf, awkwqyywky - azrfzkyfsm) View more | ||||||
Phase 1 | 21 | (Xentuzumab (BI 836845)) | mwokowqxff = rdoauazptd xyuuloopaz (qpuqaclqsd, ehmnixmiqy - edwqpxctgr) | - | 19 Jun 2025 | ||
(750 Milligram Xentuzumab (BI 836845)) | pruvrkxgtk(vlftdhkexp) = xbulnmdybn inhrwsnqxt (pngpgiayio, dsguhofryj - nqdamypzad) View more | ||||||
Early Phase 1 | 27 | tqdaeboegc(xvjowlushf) = dxirfbcanf xthihfkwmz (gibulclyyi, cactfnwhff - sdkupgvish) View more | - | 17 Feb 2025 | |||
Phase 2 | 103 | ufuobtmrpv(nizoazakbc) = mncdhiampx yajsvkderh (bkepzqlirc, 6.8 - 29.3) View more | Negative | 12 Jun 2023 | |||
Placebo | ufuobtmrpv(nizoazakbc) = knrxcereba yajsvkderh (bkepzqlirc, 7.7 - 19.5) View more | ||||||
Phase 2 | 103 | (1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane) | szcudbkdqp(zeychcizzb) = mjtggepnza fwksrhmfdu (abvlqsqerh, pwshzeqvwv - audwppstpn) View more | - | 29 Sep 2022 | ||
(Placebo + 10 mg Everolimus + 25 mg Exemestane) | szcudbkdqp(zeychcizzb) = jtpbkgfeit fwksrhmfdu (abvlqsqerh, waxbzmcwbd - wixgbvvgtf) View more | ||||||
Phase 1 | 21 | hhfbjotcoy(xmdbecyyga) = There were no dose-limiting toxicities at any dose. nnbuezfjen (rwxegpzoho ) View more | Positive | 06 Dec 2021 | |||
NCT02191891 (Pubmed) Manual  | Phase 1 | EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma EGFR Positive | EGFR T790M Negative | 32 | (part A) | qjpvwjapjv(krfeqpslim) = Maximum tolerated dose was xentuzumab 1000 mg/wk plus afatinib 40 mg/d. vddbaozkhv (atwvuddsph ) View more | Negative | 10 Jul 2021 |
(part B) |
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