JUR-003 in adults with advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

JUR-003-ONC-101 is a two-part, open-label, multicenter Phase 1a/1b trial in adults with advanced prostate cancer. The study first progresses through a dose-escalation phase to identify tolerable doses, followed by a dose-expansion phase to further evaluate safety and initial anti-tumor signals. Participants have measurable or evaluable disease and may include patients with oligometastatic disease; PSMA-PET criteria are used for a specific expansion cohort. Key safety, pharmacokinetic, pharmacodynamic, and preliminary activity data will guide future development. Enrollment occurs at selected sites in the Midwest, New York, and Tennessee.

Why it matters

Who can join: the full rules

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.

Where it's running

• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• START New York
  Lake Success, New York, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Lisa Knapp
• Email: lknapp@tcglsoleil.com
• Phone: +1 (650) 442-3367

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ASP5541 with prednisone and ADT for Chinese men with prostate cancer

  This study tests whether giving ASP5541 together with prednisone and ongoing androgen-deprivation therapy is safe and how the medicine behaves in Chinese men with metastatic prostate cancer.

  Recruiting Phase 1 Astellas Pharma Inc · Beijing, Beijing Municipality · NCT07339267

• Phase 2 test of ASP5541 for men with advanced prostate cancer

  This study will test whether an injectable form of abiraterone (ASP5541) is safe and works as well or better than the standard oral abiraterone for men with metastatic prostate cancer who are on hormone therapy, with or without prednisone.

  Recruiting at 54 sites Phase 2 Astellas Pharma Inc · Huntsville, Alabama and 53 other locations · NCT07005154

• Investigating a new treatment for advanced prostate cancer

  This study is testing a new treatment for advanced prostate cancer to see if it is safe and how well it works for patients whose cancer has spread and is resistant to other therapies.

  Recruiting at 3 sites Phase 1/2 AdvanCell Pty Limited · Brisbane, Queensland and 2 other locations · NCT05720130

• SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer

  This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.

  Recruiting Early Phase 1 Affiliated Hospital of Jiangnan University · Wuxi, Jiangsu · NCT07798778

• Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure

  This study tests whether adding rinzimetostat to darolutamide helps people with metastatic castration-resistant prostate cancer who previously took abiraterone.

  Recruiting at 15 sites Phase 3 ORIC Pharmaceuticals · Glendale, California and 14 other locations · NCT07723248

• FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer

  This study tests whether FX-111 is safe and can help treat metastatic castration-resistant prostate cancer in adult men.

  Recruiting at 7 sites Phase 1 Flare Therapeutics Inc. · Los Angeles, California and 9 other locations · NCT07719361

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.