JUR-003 in Adult Patients With Metastatic Prostate Cancer

September 11, 2026 updated by: Juri Biosciences, Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • START MidWest
    • New York
      • Lake Success, New York, United States, 11042
        • START New York
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Measurable disease per RECIST v1.1 (with PCWG3 modifications)
    2. Evaluable disease per PCWG4, as assessed by the local site Investigator/radiology
    3. 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).

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 (Dose Escalation)
Participants will receive JUR-003 to determine the recommended dose for expansion (RDE) regimen.
Biological: JUR-003
JUR-003 will be administered intravenously.
Experimental: Part 2 (Dose Expansion)
Participants will receive JUR-003 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity.
Biological: JUR-003
JUR-003 will be administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 2 years
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
2 years
Determine Recommended Dose for Expansion
Time Frame: 1 year
To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE[s]) of JUR-003
1 year
Characterize Pharmacokinetics
Time Frame: 2 years
To characterize the pharmacokinetics (PK) of JUR-003 with Cmax following administration
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juri Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • JUR-003-ONC-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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