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Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN) (WINGMEN)

Primary Purpose

Prostate Cancer

Status

Active

Phase

Early Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Xentuzumab

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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
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,

Exclusion Criteria:

A patient will not be eligible for the trial if any of the following apply:
1. Treated with corticosteroids, insulin, metformin, other oral hypoglycemic agent, or antiandrogens in the 28 days prior to first dose of study drug
2. Diabetes mellitus
3. Previous prostate radiotherapy
4. Current or previous treatment with xentuzumab or other IGF or GH -modifying therapy
5. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
6. Treatment with any other investigational agent, or treatment in another interventional clinical trial within 28 days prior to enrolment
7. 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

Sites / Locations

Churchill Hospital, Oxford University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xentuzumab

Arm Description

All patients will be allocated to receive Xentuzumab

Outcomes

Primary Outcome Measures

Assess the amount of IGF pathway blockade induced by xentuzumab

Phospho-IGF-1R and phospho-AKT (or downstream target) immunohistochemistry

Secondary Outcome Measures

Assess feasibility of treatment in the pre-prostatectomy setting

Number of patients whose radical prostatectomy is performed on schedule after 4 doses of xentuzumab.

Incidence of Treatment-Emergent Adverse Events

Treatment-related adverse events scored using CTCAE v4.03

Full Information

NCT ID

NCT05110495

First Posted

August 23, 2021

Last Updated

April 19, 2023

Sponsor

University of Oxford

Collaborators

Prostate Cancer UK, Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT05110495

Brief Title

Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN)

Acronym

WINGMEN

Official Title

Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 17, 2021 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

Prostate Cancer UK, Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xentuzumab

Arm Type

Experimental

Arm Description

All patients will be allocated to receive Xentuzumab

Intervention Type

Drug

Intervention Name(s)

Xentuzumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Assess the amount of IGF pathway blockade induced by xentuzumab

Description

Phospho-IGF-1R and phospho-AKT (or downstream target) immunohistochemistry

Time Frame

Up to 24 weeks

Secondary Outcome Measure Information:

Title

Assess feasibility of treatment in the pre-prostatectomy setting

Description

Number of patients whose radical prostatectomy is performed on schedule after 4 doses of xentuzumab.

Time Frame

Up to 24 weeks

Title

Incidence of Treatment-Emergent Adverse Events

Description

Treatment-related adverse events scored using CTCAE v4.03

Time Frame

Up to 24 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

based on gender identity

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 10*9/L Absolute Neutrophil Count (ANC) ≥ 1.5 x10*9/L Platelet count ≥ 100 x 10*9/L AST, ALT, and alkaline phosphatase ≤ 2.5 x upper limit of normal eGFR* ≥30ml/min *eGFR calculated by Cockcroft & Gault formula, Exclusion Criteria: 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

Facility Information:

Facility Name

Churchill Hospital, Oxford University Hospitals

City

Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN)

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