This is a Phase I/II open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).
Study D9890C00001 (Lumi-NHL) is modular study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed/Refractory B-NHL. Module 1 aims to study AZD4512 monotherapy at in participants in R/R B-NHL who have been exposed to at least 2 prior lines of therapy. Additional modules in specific B-NHL subtypes with AZD4512 as monotherapy or in combination with other anticancer agent(s) may be added in the future
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion
Research Site
Irvine, California, United States
RECRUITINGPercentage of participants with dose-limiting toxicities (DLTs)
To identify the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in participants with R/R B-NHL
Time frame: Up to 4 weeks
Frequency, duration, severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs)
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
Time frame: From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
Frequency of SAEs/AEs leading to discontinuation of AZD4512
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
Time frame: From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
Number of participants with clinically significant alterations in vitals signs and abnormal laboratory parameters
To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL
Time frame: From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy
Objective response rate (ORR)
ORR, according to Lugano classification 2024, to evaluate the preliminary efficacy of AZD4512 monotherapy in participants with R/R B-NHL.
Time frame: Up to 2 years
Complete response (CR) rate
CR rate, according to Lugano classification 2024, to evaluate the preliminary efficacy of AZD4512 monotherapy in participants with R/R B-NHL.
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Research Site
Jacksonville, Florida, United States
RECRUITINGResearch Site
Rochester, Minnesota, United States
RECRUITINGResearch Site
New York, New York, United States
RECRUITINGResearch Site
New York, New York, United States
RECRUITINGResearch Site
Cleveland, Ohio, United States
WITHDRAWNResearch Site
Myrtle Beach, South Carolina, United States
WITHDRAWNResearch Site
Franklin, Tennessee, United States
RECRUITINGResearch Site
Melbourne, Australia
RECRUITINGResearch Site
Chengdu, China
NOT_YET_RECRUITING...and 12 more locations
Time frame: Up to 2 years
Duration of response (DoR)
DoR, according to Lugano classification 2024, to evaluate the preliminary efficacy of AZD4512 monotherapy in participants with R/R B-NHL.
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS, according to Lugano classification 2024, to evaluate the preliminary efficacy of AZD4512 monotherapy in participants with R/R B-NHL.
Time frame: Up to 2 years
Overall survival (OS)
OS, defined as the time from the date of first dose until date of death, to evaluate the preliminary efficacy of AZD4512 monotherapy in participants with R/R B-NHL.
Time frame: Up to 2 years
Area Under plasma concentration-time Curve (AUC) of AZD4512, total antibody and total unconjugated warhead
To characterize the AUC of AZD4512 as monotherapy in participants with R/R B-NHL
Time frame: Up to 2 years
Observed plasma (peak) drug concentration (Cmax) of AZD4512, total antibody and total unconjugated warhead
To characterize the Cmax of AZD4512 as monotherapy in participants with R/R B-NHL
Time frame: Up to 2 years
Trough concentration (Ctrough) of AZD4512, total antibody and total unconjugated warhead
To characterize the Ctrough of AZD4512 as monotherapy in participants with R/R B-NHL
Time frame: Up to 2 years
Half life of AZD4512, total antibody and total unconjugated warhead
To characterize the Half life of AZD4512 as monotherapy in participants with R/R B-NHL
Time frame: Up to 2 years
Time to reach peak or maximum observed concentration (tmax) of AZD4512, total antibody and total unconjugated warhead
To characterize the Tmax of AZD4512 as monotherapy in participants with R/R B-NHL
Time frame: Up to 2 years
Total clearance of AZD4512, total antibody and total unconjugated warhead
To characterize the Total clearance of AZD4512 as monotherapy in participants with R/R B-NHL
Time frame: Up to 2 years
The number and percentage of participants who develop anti-drug antibodies (ADAs)
To determine the immunogenicity of AZD4512 as monotherapy in participants with R/R B-NHL
Time frame: Up to 2 years