A Modular Phase I/II Open-label, Multicenter Study 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-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)
Summary
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).
Detailed description
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
Arms & interventions
- DrugAZD4512
AZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion
Outcome measures
Primary
Percentage 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
Secondary
Objective response rate (ORR)
Time frame: Up to 2 years
Complete response (CR) rate
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Area Under plasma concentration-time Curve (AUC) of AZD4512, total antibody and total unconjugated warhead
Time frame: Up to 2 years
Observed plasma (peak) drug concentration (Cmax) of AZD4512, total antibody and total unconjugated warhead
Time frame: Up to 2 years
Trough concentration (Ctrough) of AZD4512, total antibody and total unconjugated warhead
Time frame: Up to 2 years
Half life of AZD4512, total antibody and total unconjugated warhead
Time frame: Up to 2 years
Time to reach peak or maximum observed concentration (tmax) of AZD4512, total antibody and total unconjugated warhead
Time frame: Up to 2 years
Total clearance of AZD4512, total antibody and total unconjugated warhead
Time frame: Up to 2 years
The number and percentage of participants who develop anti-drug antibodies (ADAs)
Time frame: Up to 2 years
Eligibility criteria
Study locations (8)
Research Site
Irvine, California, 92618
Research Site
Jacksonville, Florida, 32224
Research Site
Rochester, Minnesota, 55905
Research Site
New York, New York, 10016
Research Site
New York, New York, 10021
Research Site
Cleveland, Ohio, 44195
Research Site
Myrtle Beach, South Carolina, 29572
Research Site
Franklin, Tennessee, 37067