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Hormone Therapy

SX-682 + Enzalutamide for Prostate Cancer (SYNERGY-201 Trial)

Phase 2

Recruiting

Research Sponsored by Syntrix Biosystems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Castrate levels of serum total testosterone (<50 ng/dl) OR ongoing documented ADT.

≥ 18 years of age.

Must not have

Prior radiotherapy within 2 weeks of start of study intervention.

Known uncontrolled Human Immunodeficiency Virus (HIV) infection or active Hepatitis B or C virus infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Summary

This trial is studying a combination of SX-682 and enzalutamide in men with advanced prostate cancer that has spread and is no longer responding to standard treatment. The aim is to see if

Who is the study for?

This trial is for men with advanced prostate cancer that has spread and no longer responds to a hormone therapy called abiraterone. Participants should have adequate organ function and no other current cancers.

What is being tested?

The study tests SX-682 in combination with enzalutamide, an existing treatment, to see if it can help men whose prostate cancer has worsened despite previous hormone therapy.

What are the potential side effects?

Possible side effects may include fatigue, nausea, skin rash, high blood pressure, and changes in liver enzymes. Each person's reaction to the medication can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My testosterone levels are very low or I am on hormone therapy.

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I am 18 years old or older.

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I have advanced prostate cancer with growing or new tumors, and I've been treated with abiraterone.

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I am able to care for myself but may not be able to do active work.

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I have recovered from major side effects of my previous treatment.

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My liver tests are within normal limits.

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My kidneys work well enough, with a creatinine clearance of 50 mL/min or more.

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My blood tests show normal white blood cells, hemoglobin, and platelets.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had radiotherapy in the last 2 weeks.

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I do not have uncontrolled HIV or active Hepatitis B or C.

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My heart's electrical activity shows a prolonged QT interval.

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I do not have severe heart failure, recent heart attacks, or uncontrolled blood pressure or heart rhythm problems.

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I am currently on medication for an infection.

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I haven't had heart surgery or a heart attack in the last 6 months.

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I have not received a live vaccine in the last 30 days.

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My cancer has spread to my liver.

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I have not had major surgery in the last 3 weeks.

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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.

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I have had pneumonitis treated with steroids or have it now.

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I have untreated brain metastases or carcinomatous meningitis.

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I have been treated for an autoimmune disease in the last 2 years.

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I do not have an active tuberculosis infection.

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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Benefit

Secondary outcome measures

Adverse Events

Overall survival

Progression-free survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: SX-682 + enzalutamideExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2970

SX-682

2020

Completed Phase 2

~20

0 / 23Eligibility criteria met

Find a Location

Who is running the clinical trial?

Syntrix Biosystems, Inc.Lead Sponsor

13 Previous Clinical Trials

754 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,841 Previous Clinical Trials

41,002,836 Total Patients Enrolled

567 Trials studying Prostate Cancer

529,809 Patients Enrolled for Prostate Cancer

Syntrix BiosystemsStudy DirectorSyntrix Biosystems, Inc.

~35 spots leftby Jun 2026

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