Actively Recruiting
Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer
Led by Syntrix Biosystems, Inc. · Updated on 2025-12-22
53
Participants Needed
6
Research Sites
188 weeks
Total Duration
On this page
Sponsors
S
Syntrix Biosystems, Inc.
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial 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 prior therapy with androgen receptor pathway inhibitors.
CONDITIONS
Official Title
Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent approved by Institutional Review Board or Independent Ethics Committee
- Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) with any histology
- Currently on or previously treated with abiraterone/prednisone, darolutamide, apalutamide, or enzalutamide with documented progression
- Rising PSA confirmed by at least 3 measurements, with the last level above 2 ng/mL, or progression of bone or soft tissue metastatic lesions
- Availability of archival tumor tissue for review and studies
- Castrate serum testosterone levels (<50 ng/dl) or ongoing androgen deprivation therapy
- Karnofsky performance status of 70 or higher
- Age 18 years or older
- Life expectancy of at least 6 months
- Recovered to Grade 2 or less toxicity from prior therapy
- Adequate bone marrow function: ANC ≥ 1.2 × 10^9/L without growth factors in past 7 days, hemoglobin ≥ 9.0 g/dL without recent transfusion, platelet count ≥ 75 × 10^9/L without recent transfusion
- Adequate liver function: total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome), AST/ALT ≤ 3 × institutional ULN
- Adequate renal function: creatinine clearance ≥ 50 mL/min
- Willingness to use medically acceptable birth control if not surgically sterile or with partners not postmenopausal, during study and for 90 days after last dose
- Able and willing to provide written informed consent and HIPAA authorization
You will not qualify if you...
- Prior systemic anticancer treatments including docetaxel or marketed antibodies within 4 weeks before study
- Prior radium-223 therapy within 6 weeks
- Prior PSMA-Lu177-617 therapy within 4 weeks
- Prior ketoconazole use, two or more chemotherapy regimens with docetaxel, or any chemotherapy other than docetaxel
- Presence of liver metastases on imaging
- Radiotherapy within 2 weeks before study start unless recovered and no corticosteroids needed; 1-week washout for palliative radiation ≤2 weeks
- Major surgery requiring general anesthesia within 3 weeks before study
- Live vaccine within 30 days before first dose
- Participation in investigational agent or device study within 4 weeks prior
- Immunodeficiency or systemic steroid use exceeding 10 mg prednisone equivalent daily within 7 days before first dose
- Severe heart conditions including congestive heart failure NYHA Class III or IV, recent myocardial infarction, uncontrolled hypertension or arrhythmias
- History of second malignancy unless treated with no evidence for 2 years
- Active untreated CNS metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Uncontrolled HIV infection or active hepatitis B, hepatitis C, or TB infection
- Conditions or therapies that may affect study results or participation
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Prior allogenic tissue or solid organ transplant
- Use of medications that strongly affect CYP3A4 or prolong QT interval unless essential and no alternatives
- QTcF interval >470 msec or congenital long QT syndrome
- Recent coronary artery procedures or heart events within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
5
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
6
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
S
Syntrix Biosystems Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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