Correlate Biomarkers for the SYNERGY- 201 Study

NCT ID: NCT07050433

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-07

Study Completion Date

2026-10-31

Brief Summary

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This study is a companion to the SYNERGY-201 clinical trial (NCT06228053), which investigates SX-682 and enzalutamide in individuals with prostate cancer. Individuals must be participating in SYNERGY-201 in order to participate in this study. The purpose of this companion study is to learn more about biomarkers, particularly a biomarker called CXCR2, and investigate if CXCR2 can predict who will receive benefit from the SYNERGY-201 drug combination. This study will also investigate how CXCR2 and other biomarkers change over time when participants receive the SYNERGY-201 drug combination. CXCR2 is of particular interest because the SYNERGY-201 drug, SX-682, inhibits CXCR2. After participants provide consent, blood samples will be collected for research purposes at three SYNERGY-201 visits (Baseline, Cycle 3 Day 1 and End of Study Drug). Up to 20 participants will also receive tumor biopsies at the Baseline and SYNERGY-201 Cycle 3 Day 1 visits. Clinical and study data collected as part of SYNERGY-201 will also be used for this study.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Men who are participating in the SYNERGY-201 clinical trial (NCT06228053).

Men with metastatic castration resistant prostate cancer (mCRPC) who are participating in the SYNERGY-201 clinical trial (NCT06228053) and who also agree to participate in this study will have blood collected for circulating tumor DNA (ctDNA) and immune cell profiling assessments and other research assessments at baseline, Cycle 3 Day 1 of SYNERGY-201 and at the time of the decision to discontinue the SYNERGY-201 study drug. A subset of up to 20 participants will also undergo tumor biopsies at the baseline and Cycle 3 Day 1 visits of SYNERGY-201.

CXCR2 as a biomarker

Intervention Type DIAGNOSTIC_TEST

CXCR2 biomarker expression will be measured in tumor and immune cell samples

Interventions

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CXCR2 as a biomarker

CXCR2 biomarker expression will be measured in tumor and immune cell samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide written informed consent for this study and HIPAA authorization for the release of personal health information.
* Age \>18
* Participating in the SYNGERY-201 clinical trial.

Exclusion Criteria

* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study
* History or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the subject's participation for the full duration of the study
* History or current evidence of any condition, therapy, or laboratory abnormality that is not in the best interest of the subject to participate (in the opinion of the treating investigator)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Prostate Cancer Foundation

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Armstrong, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kellie Shobe, MS, BSN, RN

Role: CONTACT

919-684-8299

Monika Anand, PhD

Role: CONTACT

919-681-8838

Facility Contacts

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Monika Monika Anand, PhD

Role: primary

919-681-8838

Kellie Shobe, MS, BSN, RN

Role: backup

919-684-8299

Other Identifiers

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Pro00115687

Identifier Type: -

Identifier Source: org_study_id

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