VERU-111 for Prostate Cancer

(VERACITY Trial)

No longer recruiting at 50 trial locations

Overseen By Rodriguez

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Veru Inc.

Must be taking: Androgen deprivation therapy

Must not be taking: Warfarin, Taxane chemotherapy

Disqualifiers: Small cell carcinoma, Brain metastases, Hepatitis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new treatment called VERU-111, an experimental therapy for prostate cancer that continues to grow despite standard treatments. Participants will receive either VERU-111 or an alternative treatment targeting androgen receptors, proteins involved in prostate cancer growth. The trial seeks men with advanced prostate cancer who have tried at least one other treatment without success and show visible signs of cancer spreading. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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

The trial does not specify if you need to stop taking your current medications. However, you must continue androgen deprivation therapy (ADT) if you are already on it.

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

Research has shown that VERU-111, also known as Sabizabulin, has been tested for safety in patients with advanced prostate cancer unresponsive to hormone therapy. Previous studies found that VERU-111 was generally well-tolerated. These safety studies aimed to determine the highest dose patients could take without serious side effects, and no major safety issues were reported.

In other studies, VERU-111 reduced the time patients needed assistance with breathing machines, indicating some level of safety in different situations. However, every treatment can have side effects, and individual experiences may vary.

While results from earlier studies are encouraging, this treatment remains under investigation. It is important to discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard androgen receptor-targeting treatments for metastatic castration-resistant prostate cancer (mCRPC), VERU-111 offers a fresh approach by disrupting microtubules within cancer cells. This innovative mechanism stands out because it doesn't rely on typical hormone pathways, potentially overcoming resistance to current therapies like enzalutamide or abiraterone. Researchers are particularly excited about VERU-111 because it could provide an effective option for patients who have already failed other androgen receptor-targeting therapies, offering hope for better outcomes.

What evidence suggests that VERU-111 could be an effective treatment for metastatic castration-resistant prostate cancer?

Research has shown that VERU-111, a pill, may help treat advanced prostate cancer unresponsive to other treatments. Participants in this trial will receive either a 32mg or 26mg dose of VERU-111, taken orally once a day. Earlier studies demonstrated that VERU-111 stopped cancer cell growth and proved effective for patients who had tried other therapies. It was also safe and easy to take daily. These early findings suggest that VERU-111 could be a promising option for patients who haven't had success with other treatments. ^{3 5 6 7 8}

Who Is on the Research Team?

Barnette

Principal Investigator

Veru Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Known castration resistant prostate cancer, defined according to PCWG3 criteria.

Absolute PSA ≥2.0 ng/ml at screening.

Provide informed consent.

Exclusion Criteria

Patients with a QT interval corrected by Fridericia's formula of >480 ms

Patients receiving full dose warfarin therapy are not eligible for study

Patients with prior history of a thromboembolic event within the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VERU-111 or an alternative androgen receptor targeting agent until radiographic progression is observed

Approximately 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VERU-111

How Is the Trial Designed?

Group I: Either VERU-111 32mg or 26mg dose will be supplied as capsules 1 orally once a day Experimental Treatment 1 Intervention

32mg of VERU-111 26mg of VERU-11

Group II: Active control alternative androgen receptor targeting agent Active Control 1 Intervention

The alternative androgen receptor targeting agent will be administered according to the dosing instructions in the current product prescribing information.

Who Is Running the Clinical Trial?

Veru Inc.

Lead Sponsor

Trials

11

Recruited

750+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7007836/

An orally available tubulin inhibitor, VERU-111 ... Among these, VERU-111, also named ABI-231, showed the most potent anti-proliferative activity against five melanoma and prostate cancer cell lines and is the ...

2. ir.verupharma.com ir.verupharma.com/news-events/press-releases/detail/60/veru-reports-positive-phase-2-clinical-results-of-veru-111

Veru Reports Positive Phase 2 Clinical Results of ... ... results –. – Primary efficacy endpoint in hospitalized patients shows VERU-111 treatment had statistically significant 81% relative reduction ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022356524000259

VERU-111, an orally available tubulin inhibitor, suppresses ... In vivo, VERU-111 had profound antiproliferative efficacy on primary ovarian tumors. Importantly, VERU-111 completely suppressed metastasis in 100% of mice.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.6_suppl.131

Clinical study of VERU-111, an oral cytoskeletal disruptor, ... Conclusions: Based upon this Phase 1b/2 clinical trial, oral VERU-111 has a favorable safety profile allowing for chronic administration and ...

5. onclive.com onclive.com/view/veru-111-elicits-early-efficacy-signals-in-pretreated-mcrpc

VERU-111 Elicits Early Efficacy Signals in Pretreated ... “The data from the phase I study showed VERU-111 is safe and well tolerated at continuous daily dosing,” said Mark Christopher Markowski, MD, ...

6. urologytimes.com urologytimes.com/view/dr-pieczonka-on-initial-efficacy-and-safety-data-for-sabizabulin-veru-111-in-mcrpc

Dr. Pieczonka on initial efficacy and safety data for ... According to Pieczonka, additional phase 2 data for VERU-111 will be shared in September at the upcoming 2021 ESMO Annual Meeting. A phase 3 ...

7. medchemexpress.com medchemexpress.com/veru-111.html?srsltid=AfmBOooqQT3QtjA0b_EzqKwWXDiCMq01hT4ZFwX1SsMqawAI6g7HnTiE

Sabizabulin (VERU-111) | Tubulin Inhibitor VERU-111 (ABI-231) is a potent and orally active α and β tubulin inhibitor, which displays strong antiproliferative activity, with an average IC50 of 5.2 nM ...

8. onclive.com onclive.com/view/dr-klein-on-the-safety-of-veru-111-in-mcrpc

Dr. Klein on the Safety of VERU-111 in mCRPC The goal of the study was to establish a maximum-tolerated dose of VERU-111 in patients with mCRPC, as well evaluate the safety of the agent, Klein explains.