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RecruitingPhase 1

JUR-003 in Adult Patients With Metastatic Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests JUR-003 in adults with prostate cancer that has spread. It is the first study of this drug in humans and will test different doses. Researchers will check its safety, how the body handles it, and whether it may help fight 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old when you sign the consent form.
  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue or cell test.
  • Have cancer that can be measured or checked using the study’s rules. For one study group, you may instead qualify if a special scan called PSMA-PET shows cancer that has spread and a PSA blood test shows the cancer has returned (PSA at least 0.2 ng/mL).

Who can't join

  • Have a condition that weakens your immune system, HIV, active or long-term hepatitis B or C, or a past stem cell, bone marrow, or organ transplant.
  • Have an active disease where the immune system attacks the body that needed whole-body treatment in the past 2 years. This rule does not cover conditions caused by immune-based cancer treatment.
  • Have had lung swelling not caused by infection that needed steroids, or have certain active diseases that cause lung swelling or scarring.
  • Have active cancer in the brain, spinal cord, or their lining. Some groups using JUR-003 alone allow treated brain or spinal cord cancer that is stable on repeat scans for at least 2 weeks, causes no worsening symptoms, and needs no steroids for at least 14 days before treatment.
  • Have untreated pressure on the spinal cord. Nerve-related symptoms must be stable without steroids for at least 4 weeks before treatment.
  • Have had another cancer within 3 years before screening. Exceptions include certain treated skin cancers, cancers that have not spread beyond their starting layer, and some cured or low-risk tumors.
  • Have a mental health or substance use disorder that would make it hard to follow study requirements.
  • Have had a blood clot in a vein, such as a clot in the lung, within 1 month before the first dose. An uncomplicated clot in a deep vein that is mild or moderate does not rule you out.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (4)

MI

NY

TN

TX