SX-682 + Enzalutamide for Prostate Cancer

(SYNERGY-201 Trial)

Recruiting at 5 trial locations

Overseen By Syntrix Biosystems Clinical Trials

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Syntrix Biosystems, Inc.

Must be taking: Abiraterone, Prednisone

Must not be taking: Docetaxel, Enzalutamide

Disqualifiers: Liver metastases, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 30 weeks

53 Participants Needed

Trial Summary

What is the purpose of this 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 abiraterone.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it does mention that you cannot take certain medications that strongly affect liver enzymes (CYP3A4) or those that prolong the QT interval on an ECG. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug Enzalutamide for prostate cancer?

Research shows that Enzalutamide is effective in treating castration-resistant prostate cancer (CRPC), as it significantly improves survival rates and reduces prostate-specific antigen (PSA) levels, which are markers of cancer activity. ^{1 2 3 4 5}

What makes the drug SX-682 + Enzalutamide unique for prostate cancer treatment?

The combination of SX-682 with Enzalutamide is unique because Enzalutamide is a potent inhibitor of the androgen receptor signaling pathway, which is crucial in the progression of castration-resistant prostate cancer (CRPC). This combination aims to enhance the effectiveness of Enzalutamide, which has already been shown to improve survival rates in CRPC patients by targeting androgen receptor signaling. ^{1 2 3 4 5}

Research Team

Syntrix Biosystems

Principal Investigator

Syntrix Biosystems, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

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

Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures.

Exclusion Criteria

I have had cancer treatment recently.

I have not had radiotherapy in the last 2 weeks.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SX-682 plus enzalutamide for ten 21-day treatment cycles

30 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• Enzalutamide
• SX-682

Trial Overview 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.

Participant Groups

Group I: SX-682 + enzalutamide Experimental Treatment 2 Interventions

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in European Union as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in Canada as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in Japan as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Who Is Running the Clinical Trial?

Syntrix Biosystems, Inc.

Lead Sponsor

Trials

14

Recruited

810+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Enzalutamide is an effective androgen receptor inhibitor that improves overall survival in patients with metastatic castration-resistant prostate cancer, showing a 4.8-month survival benefit in those previously treated with docetaxel, as demonstrated in the Phase III AFFIRM trial.

The FDA has expanded enzalutamide's approval to include first-line treatment for metastatic castration-resistant prostate cancer in patients who have not yet received chemotherapy, and it is associated with an acceptable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzalutamide for patients with metastatic castration-resistant prostate cancer. Ramadan, WH., Kabbara, WK., Al Basiouni Al Masri, HS.[2020]

Enzalutamide, a treatment for metastatic castration-resistant prostate cancer, was linked to a case of acute generalized exanthematous pustulosis (AGEP) in a 62-year-old male patient, indicating a potential skin-related side effect of this medication.

The patient's skin reaction occurred shortly after starting enzalutamide and resolved within four weeks, suggesting that the long half-life of enzalutamide (5.8 days) may contribute to the prolonged duration of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzalutamide induced acute generalized exanthematous pustulosis. Alberto, C., Konstantinou, MP., Martinage, C., et al.[2020]

In a phase 3 trial involving 1401 men with nonmetastatic, castration-resistant prostate cancer, enzalutamide significantly improved median overall survival to 67.0 months compared to 56.3 months for placebo, indicating a 27% lower risk of death.

The safety profile of enzalutamide was consistent with previous studies, with a similar rate of serious adverse events compared to placebo, primarily involving fatigue and musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. Sternberg, CN., Fizazi, K., Saad, F., et al.[2021]

Enzalutamide (XTANDI) is an FDA-approved treatment for castration-resistant prostate cancer (CRPC) that effectively targets androgen receptor signaling, which is crucial for cancer progression.

In a Phase III clinical trial involving men with CRPC after chemotherapy, enzalutamide was well tolerated and significantly improved overall survival by 4.8 months, as indicated by reduced serum prostate-specific antigen (PSA) levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients. Dhingra, R., Sharma, T., Singh, S., et al.[2021]

Oral enzalutamide (Xtandi®) is an effective treatment for castration-resistant prostate cancer (CRPC), showing efficacy in both nonmetastatic and metastatic cases, as well as in patients who have or have not undergone chemotherapy.

Enzalutamide is generally well tolerated and is particularly beneficial for high-risk nonmetastatic CRPC patients, making it a key first-line treatment option for those with metastatic CRPC, regardless of their chemotherapy history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enzalutamide: A Review in Castration-Resistant Prostate Cancer. Scott, LJ.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Enzalutamide for patients with metastatic castration-resistant prostate cancer. [2020]

2. Poland pubmed.ncbi.nlm.nih.gov

Enzalutamide induced acute generalized exanthematous pustulosis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Enzalutamide: A Review in Castration-Resistant Prostate Cancer. [2021]