NCT06228053 · Syntrix Biosystems, Inc.
Study of SX-682 Plus Enzalutamide in Men With Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer
(SYNERGY-201)
What this study is about
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 abiraterone.
View original scientific description
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 abiraterone.
Interventions
DRUG
SX-682
Specified dose twice daily
DRUG
Enzalutamide
Specified dose once daily
Primary outcome measures
Clinical Benefit
Time frame: Ten 21-day treatment cycles
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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) with documented progression in either the mCRPC or mHSPC settings, and 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 abiraterone 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 correlat
Where
- Los Angeles, California
- San Francisco, California
- Ann Arbor, Michigan
- Minneapolis, Minnesota
- Durham, North Carolina
- Madison, Wisconsin
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations