Metastatic Castration Resistant Prostate CancerPhase 1NCT07824349
JUR-003 in Adult Patients With Metastatic Prostate Cancer
A Phase 1 study testing JUR-003 in people with Metastatic Castration Resistant Prostate Cancer and Oligometastatic Prostate Cancer (OMPC), run by Juri Biosciences, Inc. at 4 sites in United States.
Trial summary
JUR-003-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of JUR-003 in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC), Metastatic Hormone Sensitive Prostate Cancer
- What is being tested?
- JUR-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2026to Jun 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥18 years of age at the time the informed consent form (ICF) is signed.
- Has a histologically or cytologically confirmed adenocarcinoma of the prostate.
- Has either of the following:
- Measurable disease per RECIST v1.1 (with PCWG3 modifications)
- Evaluable disease per PCWG4, as assessed by the local site Investigator/radiology
- For Part 2.1B (omPC expansion) only: PSMA-avid disease on PSMA-PET, defined as lesion(s) demonstrating uptake above blood pool (PSMA score ≥1) and assessed by the Investigator as consistent with metastatic prostate cancer, in the setting of biochemical recurrence (PSA ≥0.2 ng/mL).
Who cannot join
- Has a diagnosis of immunodeficiency.
- Has had a prior stem cell, bone marrow, or organ transplant.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Has a history of (noninfectious) pneumonitis that required steroids or current active organizing pneumonitis/interstitial lung disease.
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- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated CNS metastases may participate in JUR-003 monotherapy cohorts (Parts 1.1, 2.1, and 1.3 where applicable) provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging [note that the repeat imaging should be performed during study Screening]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study drug.
- Has untreated spinal cord compression. Individuals must be neurologically stable off steroids for at least 4 weeks prior to first dose of study drug.
- Has a history of a previous secondary malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy or other localized, low-grade tumors deemed cured, or whose natural history does not have the potential to interfere with the safety or efficacy assessments of the current study and not treated with systemic anticancer therapy [except hormonal therapy]).
- Has a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.
- Has a history of venous thromboembolic events (eg, pulmonary embolism) within 1 month prior to the first dose of JUR-003. Uncomplicated (Grade ≤2) deep vein thrombosis is not considered exclusionary.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
START New York
Lake Success, New York, 11042
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
START San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of JUR-003 in Adult Patients With Metastatic Prostate Cancer
JUR-003-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of JUR-003 in patients with prostate cancer. This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.
- Conditions
- Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC), Metastatic Hormone Sensitive Prostate Cancer
- Being tested
- JUR-003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUR-003Biological
JUR-003 will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Participants will receive JUR-003 to determine the recommended dose for expansion (RDE) regimen. Receives: Biological: JUR-003 |
| Part 2 (Dose Expansion) | Experimental | Participants will receive JUR-003 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity. Receives: Biological: JUR-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The safety and tolerability of JUR-003 in patients with prostate cancer measured by frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), adverse events of special interest (AESIs), adverse events (AEs) leading to dose interruption and of adverse events (AEs) leading to treatment discontinuation
Measured: 2 years
Determine Recommended Dose for Expansion
To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE[s]) of JUR-003
Measured: 1 year
Characterize Pharmacokinetics
To characterize the pharmacokinetics (PK) of JUR-003 with Cmax following administration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juri Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824349
- Sponsor's protocol ID
- JUR-003-ONC-101
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No