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Metastatic Castration-resistant Prostate CancerPhase 2SYNERGY-201NCT06228053

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

A Phase 2 study testing SX-682 and Enzalutamide in people with Metastatic Castration-resistant Prostate Cancer, run by Syntrix Biosystems, Inc. at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
SX-682 and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
6 sitesUnited States
Study dates
18 Nov 2024to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures.
  • 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.
  • 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.
  • Castrate levels of serum total testosterone (<50 ng/dl) OR ongoing documented ADT.
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  • Karnofsky performance status of 70 or higher.
  • ≥ 18 years of age
  • Life expectancy of ≥ 6 months
  • Recovered to ≤ Grade 2 toxicity from prior therapy (per CTCAE Version 5.0)
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) ≥ 1.2 × 10^9/L without any growth factors in prior 7 days
  • Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the prior 14 days
  • Platelet count ≥ 75 × 10^9/L with no platelet transfusion in the prior 7 days
  • Adequate hepatic function:
  • Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome)
  • AST (serum glutamic oxaloacetic transaminase [SGOT]) / ALT (serum glutamic pyruvate transaminase [SGPT]) ≤ 3 × institutional ULN
  • Adequate renal function:
  • Creatinine clearance per Cockcroft-Gault equation (or institutional equivalent) of ≥ 50 mL/min
  • Willingness of patients who are not surgically sterile or with partners who are not postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment, including 90 days after the last dose of study drug.
  • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

Who cannot join

  • 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. Prior receipt of (a) ketoconazole, (b) 2 or more chemotherapy regimens with docetaxel or (c) any chemotherapy other than docetaxel.
  • Current presence of liver metastases on imaging.
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  • 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.
  • Major surgery requiring general anesthesia within 3 weeks of starting study treatment (limited biopsy or line placement is acceptable)
  • 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.
  • 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.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris; previous history of myocardial infarction within one year prior to study entry, uncontrolled hypertension, or uncontrolled arrhythmias.
  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
  • Has known active untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment greater than prednisone 10 mg daily (or equivalent) for at least 14 days prior to first dose of study intervention.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known uncontrolled Human Immunodeficiency Virus (HIV) infection based on detectable HIV viral load and abnormal CD4 count of <350/mm^3.
  • Has a known active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Has a known active TB (Bacillus Tuberculosis) infection.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known current psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has had an allogenic tissue/solid organ transplant.
  • Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4, or (b) QT prolonging as defined in the drug's approved label, with the exception of drugs that are considered absolutely essential for the care of the subject or if the Investigator believes that beginning therapy with such medication is vital to an individual subject's care while on study, and in either case, there is no alternative drug (if exceptions apply contact Syntrix medical monitor prior to enrollment).
  • ECG demonstrating a QTcF interval > 470 msec or patients with congenital long QT syndrome.
  • Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Syntrix Biosystems Clinical Trials contact

253-833-8009 ext. 21

clinicaltrials@syntrixbio.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Syntrix Biosystems Clinical Trials, clinicaltrials@syntrixbio.com

    Zachery R. Reichert, MD, PhD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Julia Hurrelbrink, julia.hurrelbrink@duke.edu

    Andrew J. Armstrong, MD, ScM, FACP

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Rosa Lara Vazquez, ravazquez@mednet.ucla.edu

    Adam E. Singer, MD, PhD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    UW Carbone Cancer Center - Cancer Connect, 800-622-8922, cancerconnect@uwcarbone.wisc.edu

    Douglas G. McNeel, MD, PhD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Syntrix Biosystems Clinical Trials, clinicaltrials@syntrixbio.com

    Not yet recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Cody Pham, cody.pham@ucsf.edu

    Danny Avins, daniel.avins@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
SX-682, Enzalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SX-682Drug

    Specified dose twice daily

  • EnzalutamideDrug

    Also called Xtandi

    Specified dose once daily

Study groups in NCT06228053
Study groupRoleWhat they receive
SX-682 + enzalutamideExperimentalNot described
Receives: Drug: SX-682; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Benefit

    A composite endpoint defined as 1) iRECIST iCR or iPR, 2) PSA50 or 3) stable disease by iRECIST and PCWG3 bone scan criteria for at least 6 months

    Measured: Ten 21-day treatment cycles

Secondary outcomes (3)

  1. Adverse Events

    Number of participants experiencing adverse events (AEs)

    Measured: Ten 21-day treatment cycles

  2. Progression-free survival

    Time from the date study treatment starts to the earliest progression event

    Measured: Ten 21-day treatment cycles

  3. Overall survival

    The time from the start of study treatment until death due to any cause

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start18 Nov 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228053
Sponsor's protocol ID
SX682-CRPC-201
Other IDs
R44CA278187
Acronym
SYNERGY-201
Status last verified
May 2026
First submitted
19 Jan 2024
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SX-682 and Enzalutamide in people with Metastatic Castration-resistant Prostate Cancer, run by Syntrix Biosystems, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Syntrix Biosystems Clinical Trials (253-833-8009 ext. 21, clinicaltrials@syntrixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit (time frame: Ten 21-day treatment cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06228053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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