Juri Biosciences, Inc.
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.
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, i…
JUR-003 will be administered intravenously.
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