Prostate CancerEarly Phase 1WINGMENNCT05110495
IGF Inhibition With Xentuzumab Prior to Radical Prostatectomy
A Early Phase 1 study testing Xentuzumab in people with Prostate Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Xentuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Dec 2021to 27 May 2023
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient will be eligible for inclusion in this study if all of the following criteria apply.
- Men with prostate adenocarcinoma confirmed on prostate biopsy and with sufficient cancer-containing biopsy tissue surplus to diagnostic need to provide 2 sections for primary endpoint analysis.
- Scheduled for open or robotic radical prostatectomy
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 1)
- The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study
Show all 11Show fewer
- Participant is willing and able to give informed consent.
- Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 70 days thereafter.
- Adequate hematologic, renal and hepatic function, defined as follows:
- Laboratory Test Value required Hemoglobin (Hb) ≥90g/L White Blood Count (WBC) >2.5 x 109/L Absolute Neutrophil Count (ANC) ≥ 1.5 x109/L Platelet count ≥ 100 x 109/L AST, ALT, and alkaline phosphatase ≤ 2.5 x upper limit of normal eGFR ≥30ml/min
- eGFR calculated by Cockcroft \& Gault formula,
Who cannot join
- A patient will not be eligible for the trial if any of the following apply:
- Treated with systemic corticosteroids, insulin, metformin, other oral hypoglycemic agent, or anti-androgens in the 28 days prior to first dose of study drug
- Diabetes mellitus
- Previous prostate radiotherapy
- Current or previous treatment with xentuzumab or other IGF or GH -modifying therapy
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
- Treatment with any other investigational agent, or treatment in another interventional clinical trial within 28 days prior to enrolment
- Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Churchill Hospital, Oxford University Hospitals
Oxford, OX3 7LE
About this study
Official title: Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN)
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
- Conditions
- Prostate Cancer
- Being tested
- Xentuzumab
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XentuzumabDrug
The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance
| Study group | Role | What they receive |
|---|---|---|
| Xentuzumab | Experimental | All patients will be allocated to receive Xentuzumab Receives: Drug: Xentuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change of Phospho-IGF-1R Positive Tumour Cells Following Treatment With Xentuzumab
Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained with phospho-IGF-1R. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-IGF-1R in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.
Measured: From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.
Percentage Change of Phospho-S6 Positive Tumour Cells Following Treatment With Xentuzumab
Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained by phospho-S6. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-S6 in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.
Measured: From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.
Secondary outcomes (4)
Number of Participants Who Had at Least 4 Doses of Xentuzumab and Proceeded to Have Surgery Per the Protocol Schedule
This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting.
Measured: From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.
Median Delay in Surgery in Participants Who Had More Than 4 Doses of Xentuzumab (and Whose Surgery Was Delayed by Factors Other Than Trial Treatment)
All participants who had more than 4 doses of xentuzumab were considered to have had their surgery delayed by factors other than trial treatment. Per protocol, all participants who had delayed surgery received additional weekly doses of xentuzumab. Reason for delay was not recorded as part of the study dataset. This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting.
Measured: From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.
Number of Patients Experiencing an Adverse Event (AE) or Serious Adverse Event (SAE) While On-trial
This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting. AEs \& SAEs were graded using CTCAE v5.0, with higher grades considered to be worse outcomes.
Measured: From consent at week -1 to the end of study visit at up to 19 weeks
Number of Patients With Any Adverse Event Assessed as Treatment-Related (TRAE) While On-trial
Number of patients with any TRAE from the time of consent to the end of study visit. TRAEs are AEs that are investigator-determined to be definitely, probably or possibly related to treatment with xentuzumab and graded using CTCAE v5.0, with higher grades considered to be worse outcomes.
This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting.
Measured: From consent at week -1 to the end of study visit at up to 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start17 Dec 2021
- Primary completion20 Mar 2023
- Study completion27 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a phase 0 'window of opportunity' study testing whether xentuzumab blocks IGF signalling and markers of growth in men with localised prostate cancer scheduled for radical prostatectomy
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer UK, Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Simon Lord, Prof, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110495
- Sponsor's protocol ID
- OCTO-084
- Acronym
- WINGMEN
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2021
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No