GZ17-6.02 for Prostate Cancer

Overseen By Massey IIT Research Operations

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Virginia Commonwealth University

Must be taking: Androgen deprivation therapy

Must not be taking: MAOIs, CYP inhibitors, PARP inhibitors

Disqualifiers: Brain metastasis, Hepatitis B/C, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a new treatment, GZ17-6.02 (an experimental treatment), can slow the progression of advanced prostate cancer that hasn't responded to usual treatments. The focus is on men whose cancer continues to grow despite hormone treatments. Candidates may be suitable if their prostate cancer has worsened after treatments like ADT and other hormone blockers, and they can undergo regular testing and follow study rules. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does require stopping certain drugs that might interact with the study treatment at least 2 weeks before starting. If you're taking monoamine oxidase inhibitors, you need to stop them 10 days before starting the trial.

Is there any evidence suggesting that GZ17-6.02 is likely to be safe for humans?

Research has shown that GZ17-6.02 has been studied for its safety and effects on prostate cancer cells. In lab and animal studies, GZ17-6.02 killed prostate cancer cells, suggesting it targets cancer cells effectively. However, this early-phase trial primarily focuses on assessing safety in humans.

Early-phase studies determine how well a treatment is tolerated and identify any side effects. As a Phase 1 trial, researchers are still learning about the safety of GZ17-6.02. Participants in this trial will provide important information on side effects and how the body processes the drug.

In short, GZ17-6.02 might safely help with prostate cancer, but more data from this trial will offer clearer answers about its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for prostate cancer, like hormone therapy and chemotherapy, target the cancer cells in a general way, often affecting healthy cells too. But GZ17-6.02 is unique because it specifically targets cancer cells with a new active ingredient, aiming to minimize damage to normal cells. Researchers are excited because this precision could lead to fewer side effects and potentially more effective results compared to existing therapies.

What evidence suggests that GZ17-6.02 might be an effective treatment for prostate cancer?

Research has shown that GZ17-6.02, the investigational agent in this trial, holds promise for treating prostate cancer. In lab studies, this treatment killed prostate cancer cells and significantly slowed tumor growth in animals. These studies also found that GZ17-6.02 extended the animals' lifespans. This suggests that GZ17-6.02 might effectively slow advanced prostate cancer in humans. These early findings offer hope that GZ17-6.02 could become a useful treatment option for this condition. ^{1 2 3 4 6}

Who Is on the Research Team?

John Melson, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

Men with advanced prostate cancer that's resistant to hormone therapy can join this trial. They must have rising PSA levels, adequate blood counts, and agree to use contraception if they have partners who could become pregnant. Participants need normal liver and kidney function, no severe infections or brain metastases, and a performance status indicating they are relatively active.

Inclusion Criteria

My PSA levels have increased over two tests at least a week apart.

Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

Platelets ≥100,000 cells/mm3

Exclusion Criteria

Any investigational agent within 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before initiating study treatment

I have a condition that affects how my body absorbs nutrients.

Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GZ17-6.02, a combination of curcumin, harmine, and isovanillin, 375mg twice daily

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• GZ17-6.02

Trial Overview The trial is testing GZ17-6.02 to see if it slows down the progression of castration-resistant prostate cancer in patients who've already tried anti-androgen therapy. It involves taking an investigational drug made from curcumin, harmine, and isovanillin.

How Is the Trial Designed?

Group I: Investigational Agent Administration Experimental Treatment 1 Intervention

GZ17-6.02: 375mg twice daily

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9671078/

GZ17-6.02 kills prostate cancer cells in vitro and in vivo In vivo, GZ17-6.02 as a single agent profoundly reduced tumor growth and significantly prolonged animal survival. GZ17-6.02 interacted with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06636123

GZ17-6.02 in Advanced CRPC After Progression on Anti- ... The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer. Detailed Description. This single- ...

3. oncotarget.com oncotarget.com/article/28558/text/

GZ17-6.02 interacts with proteasome inhibitors to kill ... We recently demonstrated that GZ17-6.02 was highly efficacious at suppressing the growth of LNCaP prostate tumors in mice, significantly ...

4. masseycancercenter.org masseycancercenter.org/clinical-trials/clinical-trial-details/gz17-602-in-advanced-castration-resistant-prostate-cancer-crpc-after-progression-on-anti-androgen-th

GZ17-6.02 in Advanced Castration-Resistant Prostate ... Assess the efficacy of GZ17-6.02 in improving the rate of disease control, defined as radiographic progression-free survival for 6 months or more, i.e. ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36408163/

GZ17-6.02 kills prostate cancer cells in vitro and in vivo In vivo, GZ17-6.02 as a single agent profoundly reduced tumor growth and significantly prolonged animal survival.

6. clinicaltrial.be clinicaltrial.be/en/details/66037?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Study Evaluating GZ17-6.02 in Patients With Advanced Soli... This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a novel anti-cancer drug, GZ17-6.02 administered to ...