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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the effectiveness of a new treatment combination using SX-682 (an experimental treatment) and enzalutamide for men with metastatic castration-resistant prostate cancer (mCRPC). This type of cancer has spread to other parts of the body and continues to grow despite low testosterone levels. The trial targets patients whose cancer has progressed after receiving abiraterone. Men who have experienced a rise in PSA levels (a protein indicating cancer activity) or have seen their cancer spread further are suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that enzalutamide is generally safe and well-tolerated for people with prostate cancer. This drug blocks male hormones that can promote cancer growth. Studies have found that it can extend life and has a lower risk of serious side effects compared to other treatments.

For SX-682, less information is available about its safety because it remains under study. This trial is in an earlier stage, so researchers are still gathering evidence on how well people tolerate SX-682.

The trial tests whether using enzalutamide and SX-682 together is more effective than using enzalutamide alone. While enzalutamide has a good safety record, the combination with SX-682 is new and still under investigation for safety in humans. Participants in the trial contribute to researchers' understanding of this. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for prostate cancer?

Researchers are excited about SX-682 combined with enzalutamide for prostate cancer because it targets a new mechanism that current treatments don't address. While most treatments for prostate cancer, like hormone therapies, focus on blocking androgen receptors to slow cancer growth, SX-682 works by inhibiting the CXCR1/2 pathways. This could potentially prevent cancer cells from developing resistance and make the treatment more effective over time. This novel approach offers hope for improved outcomes in patients who have limited options after traditional therapies.

What evidence suggests that the combination of SX-682 and enzalutamide could be effective for metastatic castration resistant prostate cancer?

Research shows that Enzalutamide, which participants in this trial will receive, effectively treats castration-resistant prostate cancer (CRPC), a type that doesn't respond to hormone therapy. It helps patients live longer and slows cancer growth. Men taking Enzalutamide had a 61% lower chance of their cancer worsening compared to those not taking it. SX-682, also part of the treatment in this trial, is a newer therapy under study to enhance the effectiveness of existing cancer drugs like Enzalutamide. In animal studies, SX-682 has shown promise in aiding the immune system to fight cancer. Although human studies are limited, early signs suggest it could be a valuable addition for treating advanced prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Syntrix Biosystems

Principal Investigator

Syntrix Biosystems, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06228053

NCT06228053 | Study of SX-682 Plus Enzalutamide in ... 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) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07002320?intr=SX-682&rank=4

Investigating SX-682 in Combination With Apalutamide ... ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5374023/

Effective Combinatorial Immunotherapy for Castration ... Here we developed a novel chimeric mouse model of mCRPC to efficiently test combination therapies in an autochthonous setting.

4. withpower.com withpower.com/trial/phase-2-prostatic-neoplasms-4-2024-c47b4

SX-682 + 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 ...

5. xtandi.com xtandi.com/clinical-trials

Clinical Trial Results | XTANDI® (enzalutamide) Men taking XTANDI had a 61% lower chance of their cancer progressing compared with men not taking XTANDI during the study. Progression was seen in 89 men (15.5 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12504157/

Comparative effectiveness and safety of enzalutamide ... This large-scale, real-world study demonstrates that enzalutamide is associated with improved overall survival and a lower risk of treatment ...

7. urotoday.com urotoday.com/clinical-trials/prostate-cancer/93687-a-phase-2-efficacy-and-safety-study-of-niraparib-in-men-with-metastatic-castration-resistant-prostate-cancer-and-dna-repair-anomalies.html

Clinical Trials in Urology A Phase 2 Study of a Checkpoint Inhibitor in Men With Progressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or ...