Status and phase
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid malignant tumor (including lymphoma; dose-escalation phase only) that has failed to respond to standard therapies;
Male or female patients age 18 or older;
Measurable or evaluable disease by RECIST v 1.1, or PCWG3 for prostate cancer;
Capable of understanding and complying with protocol requirements;
A life expectancy of greater than 8 weeks at Screening;
An ECOG PS of 0 to 2;
Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures;
Adequate bone marrow, liver, and renal function as defined below:
Adequate cardiac function as estimated by left ventricular ejection fraction (LVEF) > 50% by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);
Negative pregnancy test for women of childbearing potential (women of childbearing potential and men must agree to use adequate contraception [hormonal or barrier method of birth control] prior to study entry and for the duration of study participation.
[NOTE: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient]. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately).
Exclusion criteria
Primary purpose
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55 participants in 1 patient group
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Central trial contact
Robert L De Jager, MD
Data sourced from clinicaltrials.gov
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