This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).
This dose escalation and optimization study, is evaluating the safety, tolerability, PK, PD and clinical activity of AZD0486 monotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
317
AZD0486 is a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells leading to T cell-mediated cytotoxicity of malignant B cells
Research Site
Tampa, Florida, United States
Incidence of subjects with Dose-limiting toxicities (DLT)
A DLT is defined as a TEAE that is not unequivocally due to the subject's underlying malignancy or other extraneous cause. DLT evaluable subjects are defined as those subjects who receive either the target dose of AZD0486 or priming dose(s) in any step-up dose schedule and are assessed for toxicities for the 28-day evaluation period. The NCI-CTCAE version 5.0 will be used (except for CRS and NT). A DLT will be evaluated as Non-hematologic, Hematologic, Cytokine Release Syndrome (CRS), or neurotoxicity.
Time frame: 28 days
Incidence of subjects with adverse events (AEs) and/or serious adverse events (SAEs)
The incidence, timing, seriousness, and relationship to study treatment of adverse events will be evaluated.
Time frame: From screening until 90 Days after end of treatment
Maximum Observed Serum Concentration of AZD0486 (Cmax)
The maximum observed serum concentration on a concentration time curve.
Time frame: 4 Weeks
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast)
Area under the serum concentration-time curve from time zero to time of last measurable concentration.
Time frame: 4 Weeks
Apparent terminal half-life (t1/2) of AZD0486
Terminal half-life (t1/2,) will be determined after infusion in Cycle 1 using non-compartmental methods.
Time frame: From screening until 90 Days after end of treatment
Anti-Lymphoma Activity by Objective Response Rate (ORR)
Objective response rate is defined as the proportion of subjects with a confirmed partial or complete response to treatment
AstraZeneca Clinical Study Information Center
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Research Site
Louisville, Kentucky, United States
RECRUITINGResearch Site
New Brunswick, New Jersey, United States
RECRUITINGResearch Site
Charlotte, North Carolina, United States
RECRUITINGResearch Site
Columbus, Ohio, United States
RECRUITINGResearch Site
Portland, Oregon, United States
WITHDRAWNResearch Site
Pittsburgh, Pennsylvania, United States
RECRUITINGResearch Site
Austin, Texas, United States
RECRUITINGResearch Site
Houston, Texas, United States
RECRUITINGResearch Site
Milwaukee, Wisconsin, United States
RECRUITING...and 17 more locations
Time frame: 48 months
Anti-Lymphoma Activity by Progression-Free Survival (PFS)
Progression-free survival time is defined as the time from the first dose of AZD0486 to progression or death, whichever occurs first
Time frame: 48 months
Anti-Lymphoma Activity by Duration of Objective Response (DOR)
The duration of objective response for a subject is defined as the time from the initial objective response to disease progression or death, whichever occurs first
Time frame: 48 months
Anti-Lymphoma Activity by Clinical Benefit Rate
Clinical benefit rate is defined as the proportion of subjects with a confirmed complete response, partial response or minor response, or stable disease for at least 24 weeks after responding to treatment
Time frame: 48 months