The primary goal of this Phase 1 study is to characterize the safety and tolerability of DZ-002 and establish the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of DZ-002 administered on a weekly schedule in patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of DZ-002 will also be assessed.
This is a single center, first-in-human, Phase 1, safety, PK and pharmacodynamic study of DZ-002 in patients with solid tumors who have failed standard therapies. The study will be conducted in 2 phases, a dose escalation phase and a dose expansion phase. The dose-escalation phase will first determine the MTD and/or RP2D of DZ-002 in patients with advanced cancers. Subsequently, the MTD and/or RP2D will be investigated in 2 expansion treatment groups of castration-resistant prostate cancer (CRPC) and advanced pancreatic cancer. Patients who are determined to be eligible, based on Screening assessments, will be enrolled in the study and will receive their first dose of study therapy on Cycle 1 Day 1. All patients will receive DZ-102 administered as a weekly intravenous (IV) infusion on days 1, 8, 15, and 22 of a 28-day cycle. The dose of DZ-002 will be dependent on the cohort in which the patient is enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
DZ-002 Injection
Cedars-Sinai Medical Center
Los Angeles, California, United States
Incidence and severity of treatment emergent adverse events (TEAEs)
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit
Time frame: 24 months
MTD
maximum tolerated dose (MTD) of DZ-002
Time frame: 24 months
Tumor response
Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and the Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
Time frame: 24 months
AUC
Area Under the Plasma Concentration versus Time Curve of DZ-002
Time frame: 56 days
Cmax
Maximum Plasma Concentration of DZ-002
Time frame: 56 days
Tmax
Time to reach maximum (peak) plasma concentration of
Time frame: 56 days
t1/2
Terminal half-life of DZ-002
Time frame: 56 days
Clearance
Total body clearance of the drug from plasma (CL) of DZ-002
Time frame: 56 days
Volume of distribution
Apparent volume of distribution of DZ-002
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Time frame: 56 days