Recruiting

SX-682 & Enzalutamide

Sponsor:

Duke University

Code:

NCT07050433

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CXCR2 as a biomarker

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT07050433

Start date

Aug 7, 2025

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

CXCR2 as a biomarker

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

Primary outcome measure

  • Number of participants with Tumor CXCR2 biomarker expression associated with clinical benefit (CB) [ Time Frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days) ]
  • Number of participants with Immune cell CXCR2 biomarker expression associated with clinical benefit (CB) [ Time Frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days) ]

Central Contacts and Locations

Central contacts

Kellie Shobe, MS, BSN, RN

919-684-8299kellie.shobe@duke.edu

Monika Anand, PhD

919-681-8838monika.anand@duke.edu

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Contacts

Kelly Fitzgerald, MD

(415) 476-4616Kelly.Fitzgerald@ucsf.edu

Rahul Aggarwal, MD

(415) 476-4616rahul.aggarwal@ucsf.edu

Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109-2800

Contacts

Zachery Reichert, MD

800-865-1125zreiche@med.umich.edu

Zachery Reichert, MD

800-865-1125CancerAnswerLine@med.umich.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Monika Monika Anand, PhD

919-681-8838monika.anand@duke.edu

Kellie Shobe, MS, BSN, RN

919-684-8299kellie.shobe@duke.edu

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Glenn Liu, MD

800-622-8922gxl@medicine.wisc.edu

UW Clinical Trial Navigation Team Cancer Connect

800-622-8922cancerconnect@uwcarbone.wisc.edu

More Information

Sponsor

Duke University

Last update posted

Aug 27, 2026

Last verified

Feb, 2026

Keywords

  • Prostate Cancer
  • SYNERGY-201
  • SX-682
  • CXCR2 inhibition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-27.