210 Participants NeededMy employer runs this trial

JUR-003 for Prostate Cancer

Recruiting at 2 trial locations
LK
Overseen ByLisa Knapp
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Juri Biosciences, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing a new treatment called JUR-003 for prostate cancer. The goal is to determine the safety of JUR-003 and its effectiveness against tumors. The study consists of two parts: first, testing different doses to identify the optimal one, and then confirming the safety and effectiveness of that dose. Men with confirmed, measurable, or evaluable prostate cancer may be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that JUR-003 is likely to be safe for humans?

A previous study showed that patients experienced positive safety results with treatments similar to JUR-003 for prostate cancer. Research has shown that modern proton therapy, another treatment option for prostate cancer, is generally safe and can alleviate symptoms like urinary problems, with few side effects. Although direct safety data on JUR-003 is not yet available, this first-in-human Phase 1 study marks the early testing stage. Researchers aim to find the safest dose and are closely monitoring for any side effects. If JUR-003 performs well in this phase and advances to later stages, it will have demonstrated some initial safety in humans.12345

Why do researchers think this study treatment might be promising for prostate cancer?

Most treatments for prostate cancer, like hormone therapy and chemotherapy, aim to reduce or stop the growth of cancer cells by targeting hormones or using chemical agents. But JUR-003 works differently, targeting specific pathways involved in cancer cell growth with a novel mechanism of action. Researchers are excited about JUR-003 because it could offer a new approach that might be more effective or have fewer side effects compared to existing treatments. This unique approach has the potential to improve outcomes for patients who don't respond well to current therapies.

What evidence suggests that JUR-003 might be an effective treatment for prostate cancer?

Research shows that JUR-003 is a new treatment tested for prostate cancer in this trial. Although limited information exists from human studies, this treatment aims to reduce tumor activity by blocking pathways essential for cancer cell growth and survival. Early results appear promising, but further research is necessary to confirm its effectiveness. As an experimental treatment, ongoing studies are crucial to fully understand its effects. Participants in this trial will receive JUR-003 in either a dose escalation phase to determine the recommended dose or a dose expansion phase to confirm safety and anti-tumor activity.678910

Are You a Good Fit for This Trial?

This trial is for adults with prostate cancer that has spread to other parts of the body (metastatic). Participants must meet certain health requirements set by the study team. People who do not meet these criteria or have conditions that could interfere with participation will be excluded.

Inclusion Criteria

I have been diagnosed with prostate adenocarcinoma by lab tests.
I am 18 years old or older.
I have prostate cancer that can be measured or seen on scans, or PSMA-avid disease with rising PSA.

Exclusion Criteria

I have had a blood clot in my veins within the last month, except for mild DVT.
I do not have untreated or active brain or spinal cancer.
I have had lung inflammation needing steroids or currently have active lung disease.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive JUR-003 to determine the recommended dose for expansion (RDE) regimen

1 year

Dose Expansion

Participants receive JUR-003 at the RDE to confirm safety and anti-tumor activity

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • JUR-003

Trial Overview

The study is testing a new drug called JUR-003 in men with metastatic prostate cancer. It aims to find a safe dose and see how well the drug works against tumors, using two phases: first increasing doses, then expanding to more patients.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2 (Dose Expansion)Experimental Treatment1 Intervention
Group II: Part 1 (Dose Escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Juri Biosciences, Inc.

Lead Sponsor

Citations

The 5-Year Outcomes of Moderately Hypofractionated ...

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Dose-Escalated Proton Radiation Therapy for High-Risk ...

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Outcomes and toxicity from a prospective study of ...

Our results show that moderate hypofractionation with 64 Gy in 20 fractions is feasible and safe in patients with low- to intermediate-risk prostate cancer.

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Five-year results demonstrated 85.1% biochemical relapse-free survival without significant increase in toxicity. There is also randomized ...

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In our cohort, with a median follow-up of 69 months, the 5-year disease-free survival rate was 84 % with the moderately hypofractionated regimen ...

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