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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
JUR-003 will be administered intravenously.
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART New York
Lake Success, New York, United States
RECRUITINGSCRI Oncology Partners
Nashville, Tennessee, United States
NOT_YET_RECRUITINGSafety 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
Time frame: 2 years
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
Time frame: 1 year
Characterize Pharmacokinetics
To characterize the pharmacokinetics (PK) of JUR-003 with Cmax following administration
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.