Delving into the Latest Updates on Xentuzumab with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

BI-836845

Target

IGF-1 x IGF-2

Action

inhibitors

Mechanism

IGF-1 inhibitors(Insulin-like growth factor I inhibitors), IGF-2 inhibitors(Insulin-like growth factor II inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [1]

Active Indication-

Inactive Indication

Adenocarcinoma of prostateAdvanced Malignant Solid NeoplasmEGFR-mutated non-small Cell Lung Cancer+ [7]

Originator Organization

C.H. Boehringer Sohn AG & Co. KG

Active Organization-

Inactive Organization

Boehringer Ingelheim GmbH

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 164717H

Source: *****

Sequence Code 164724L

Source: *****

The WINGMEN trial aims to understand how a hormone-like protein called insulin-like growth factor (IGF) helps prostate cancers grow and become aggressive. IGF is required for normal development, and also helps cancers grow and spread. Men with high blood IGF are at increased risk of developing prostate cancer, and tall men are more likely to get aggressive prostate cancer. The WINGMEN trial will recruit 30 men with prostate cancer who have been offered an operation to remove the prostate. Most men have to wait 4-5 weeks between a decision to have prostate removal surgery, and actually having the operation. In this 4-5 week window we will offer treatment with a new IGF-blocker drug called xentuzumab. The drug is provided by Boehringer Ingelheim and the trial is funded by Prostate Cancer UK.
Xentuzumab will be given as an outpatient by once weekly intravenous infusion (drip) in the Early Phase Clinical Trials Unit, Oxford Cancer Centre, Churchill Hospital. In other trials, xentuzumab is being tested in patients with advanced cancer, and is proving to be well-tolerated. After the 4-week treatment, WINGMEN trial patients will have routine prostate removal surgery. Samples of blood and prostate cancer that are surplus to diagnostic need will be taken from the diagnostic prostate biopsy (pre-xentuzumab) and the cancer removed at surgery (after xentuzumab) for research tests. These samples will be compared to measure how effectively xentuzumab reduces signs of tumour growth, and identify which genes and proteins are switched on or off by xentuzumab, and which may therefore be important in helping IGF promote prostate cancer growth. The information we get from the WINGMEN trial may help us to improve treatment of men with prostate cancer, with the long-term aim of reducing the risk of aggressive prostate cancer

Start Date17 Dec 2021

Sponsor / Collaborator

University of Oxford

[+2]

NCT03659136

/ CompletedPhase 2

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

The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

Start Date28 Nov 2018

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT03099174

/ CompletedPhase 1

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.

This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of:
* Xentuzumab in combination with abemaciclib
* Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer.
Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib.
For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

Start Date04 May 2017

Sponsor / Collaborator

Boehringer Ingelheim GmbH

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 Xentuzumab

01 Dec 2025·BREAST

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 2025·ESMO 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 2023·British 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 ; Lin, Chia-Chi ; Bianchini, Diletta ; de Bono, Johann ; Hussain, Syed ; Maroto, José Pablo ; Lord, Simon ; Climent, Miguel Ángel ; Cook, Natalie ; Wang, Shian-Shiang ; 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
-	-	-	DB14871

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	Phase 2	United States	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Australia	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Belgium	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Canada	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	France	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Germany	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Greece	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Italy	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Portugal	Boehringer Ingelheim GmbH	28 Nov 2018
Hormone receptor positive HER2 negative breast cancer	Phase 2	Spain	Boehringer Ingelheim GmbH	28 Nov 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02204072 (CTgov)	Phase 1	Metastatic castration-resistant prostate cancer	120	Enzalutamide+Xentuzumab (Phase Ib Escalation: 750 mg Xentuzumab + 160 mg Enzalutamide)	vugegsnybb = sapdwclnep zzvqkautrk (zewoobdyvg, txpquecvno - nmmgacvuua) View more	-	15 Jul 2025
				Enzalutamide+Xentuzumab (Phase Ib Escalation: 1000 mg Xentuzumab + 160 mg Enzalutamide)	vugegsnybb = khhjqbbget zzvqkautrk (zewoobdyvg, dcvxbqjyjy - hfgthkrchx) View more
NCT02123823 (Study 1280.4, CTgov)	Phase 1	Locally advanced breast cancer \| Estrogen receptor positive breast cancer	164	Exemestane+Everolimus+BI 836845 (Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II)	zjmcgngqhl(usakbufxax) = aiymmmwqbj wzhkbmibxi (zmdiejqhph, gczxmjgqky - udvezlvkxj) View more	-	15 Jul 2025
				Exemestane+Everolimus (Everolimus 10 mg + Exemestane 25 mg - Phase II)	zjmcgngqhl(usakbufxax) = rexdrnvbbq wzhkbmibxi (zmdiejqhph, vwtkyfaomw - tdoibekmld) View more
NCT02191891 (CTgov)	Phase 1	EGFR-mutated non-small Cell Lung Cancer	32	Afatinib+Xentuzumab (Xentuzumab + Afatinib 30 Milligram (mg) - Part A)	nafmuupkhv = eaogketsxx rqdmeydshu (oohkfsynmy, wwqwliyjdi - mhkwldftwp)	-	25 Jun 2025
				Afatinib+Xentuzumab (Xentuzumab + Afatinib 40 mg - Part A)	nafmuupkhv = pcpschjpcz rqdmeydshu (oohkfsynmy, wiyqjxiwyp - rjdpmddwlo)
NCT03099174 (P3-11-05, CTgov)	Phase 1	Hormone receptor positive HER2 positive breast cancer	133	abemaciclib+Xentuzumab (Cohort A: Xentuzumab 1000 mg & 150 mg Abemaciclib)	cnxvbmbibn = azwamtudsc xsnuaoaksw (nuuchazmgk, kcflgwfohz - rylhxczrre) View more	-	24 Jun 2025
				Letrozole+abemaciclib+Xentuzumab (Cohort B: Xentuzumab 1000 mg & 150 mg Abemaciclib & 2.5 mg Letrozole)	cnxvbmbibn = nsqgvaudye xsnuaoaksw (nuuchazmgk, jlqcmcoaih - htktrujpyv) View more
NCT02145741 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm	21	Xentuzumab (BI 836845 (Xentuzumab (BI 836845))	unclahbmhf = htzulzuisp iohlqmgfhp (mlisgueopl, cyuglqknqz - dunbhgtnas)	-	19 Jun 2025
				Xentuzumab (BI 836845 (750 Milligram Xentuzumab (BI 836845))	ykyplloetk(bgbarrzvyx) = hmyesgaapj xzvftfixaw (hvsauvauax, jfzuxdopbl - fyuhjgaogl) View more
NCT05110495 (WINGMEN, CTgov)	Early Phase 1	Prostatic Cancer \| Prostate Cancer, Hereditary, 7 \| Adenocarcinoma of prostate	27	Xentuzumab	nhjtbgbrdd(fntxrxvwwa) = jeulgddaze jrbisjytuv (pxfjolmqnk, zxdosphmrw - uxbauxlgph) View more	-	17 Feb 2025
NCT03659136 (XENERA-1, Pubmed)	Phase 2	Hormone receptor positive HER2 negative breast cancer	103	Xentuzumab	qqrynuhnhr(gkypydihxo) = zxfjkvnocn ggdoytrfmr (otmouiexzl, 6.8 - 29.3) View more	Negative	12 Jun 2023
				Placebo	qqrynuhnhr(gkypydihxo) = zvrcrybgeo ggdoytrfmr (otmouiexzl, 7.7 - 19.5) View more
NCT03659136 (XENERA-1, CTgov)	Phase 2	Metastatic breast cancer \| Hormone receptor positive HER2 negative breast cancer	103	Exemestane+Everolimus+Xentuzumab (1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane)	rvobjctcnd(qjludclwnj) = ubwhpwndua hxtbotwzqh (zxygpvyeqp, fedndbbxtp - cmwgpqlnwd) View more	-	29 Sep 2022
				Placebo+Exemestane+Everolimus (Placebo + 10 mg Everolimus + 25 mg Exemestane)	rvobjctcnd(qjludclwnj) = qhcbuwfdjw hxtbotwzqh (zxygpvyeqp, dqkpxoruno - yemrxxvgbf) View more
NCT02145741 (Pubmed \| Cancer Sci) Manual	Phase 1	Solid tumor	21	xentuzumab	zndckkwhsp(wlwuvveeil) = There were no dose-limiting toxicities at any dose. csasrgjpzn (sebjpoiuan ) 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	Afatinib+Xentuzumab (part A)	tuqweekiml(yrsnkytivt) = Maximum tolerated dose was xentuzumab 1000 mg/wk plus afatinib 40 mg/d. ddnwpkocmh (lrznxrrdre ) View more	Negative	10 Jul 2021
				Afatinib+Xentuzumab (part B)

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Xentuzumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation