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Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer

A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial

NCT06228053•Syntrix Biosystems, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed prior therapy with androgen receptor pathway inhibitors.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures.
•2. 2\. Diagnosis of mCRPC with (a) any histology, and (b) currently on or previously on abiraterone/prednisone (or abiraterone/dexamethasone) or darolutamide, apalutamide or enzalutamide with documented progression in either the mCRPC or mHSPC settings, and currently with:
•* rising PSA (a rising PSA requires at least 3 measurements obtained at least 1 week apart showing increase from nadir with the last level above 2 ng/mL by local testing); or
•* progression of new or existing bone or soft tissue metastatic lesions by CT, MRI or bone scan; no washout necessary.
•3. Availability of archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and blocks) upon later request for future pathologic review and possible correlative studies.
•4. Castrate levels of serum total testosterone (\<50 ng/dl) OR ongoing documented ADT.
•5. Karnofsky performance status of 70 or higher.
•6. ≥ 18 years of age
•7. Life expectancy of ≥ 6 months
•8. Recovered to ≤ Grade 2 toxicity from prior therapy (per CTCAE Version 5.0)
+11 more criteria

Exclusion Criteria

•1. Prior systemic anticancer treatment:
•* Prior treatment with docetaxel or marketed antibody within 4 weeks of first dose of study treatment
•* Prior radium-223 therapy within 6 weeks
•* Prior PSMA-Lu177-617 therapy within 4 weeks
•2. 2\. Prior receipt of (a) ketoconazole, (b) 2 or more chemotherapy regimens with docetaxel or (c) any chemotherapy other than docetaxel.
•3. Current presence of liver metastases on imaging.
•4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
•5. Major surgery requiring general anesthesia within 3 weeks of starting study treatment (limited biopsy or line placement is acceptable)
•6. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
•7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
+16 more criteria

Locations (6)

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Duke University

Durham, North Carolina, United States

University of Wisconsin

Madison, Wisconsin, United States

Key Dates

Start Date

November 18, 2024

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2028

Last Updated

December 22, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

SX-682

DRUG

Enzalutamide

DRUG

Contacts

Syntrix Biosystems Clinical Trials

CONTACT

253-833-8009 clinicaltrials@syntrixbio.com

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer