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.
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.
Measurable disease per RECIST v1.1 (with PCWG3 modifications)
Evaluable disease per PCWG4, as assessed by the local site Investigator/radiology
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.
Sequential
JUR-003
Biological/VaccineJUR-003 will be administered intravenously.
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
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
Characterize Pharmacokinetics
To characterize the pharmacokinetics (PK) of JUR-003 with Cmax following administration
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