A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer
Summary
This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD6621. The study is split into different modules which will look at AZD6621 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels of AZD6621 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD6621 doses in a larger group of participants (dose expansion).
Detailed description
This is a first in human, modular, Phase I/II, open-label, multicenter study of AZD6621, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating safety, tolerability, PK, pharmacodynamics, and anti-tumor activity of AZD6621 in metastatic prostate cancer. The study will also characterize the PK and immunogenicity of AZD6621.
Arms & interventions
- DrugAZD6621
A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8
Outcome measures
Primary
Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE)
• Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results
Time frame: From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years)
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only)
• A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Time frame: From first study dose to 21 to 28 days post first dose
Preliminary anti-tumour activity of AZD6621 (PSA Response Rate) (Part B only)
• Number of participants with a PSA response rate
Time frame: Up to 3 years
Secondary
Preliminary anti-tumour activity of AZD6621 (PSA Response rate) (Part A only)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (time to PSA response)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (duration of PSA response)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (durable PSA response rate)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (time to PSA progression)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (Radiological Response - RECIST)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (Radiological Response - Target Lesion Percentage change)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (Overall Survival 12 months)
Time frame: 12 months
Preliminary anti-tumour activity of AZD6621 (Overall Survival)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (SSRE)
Time frame: Up to 3 years
Pharmacokinetics of AZD6621 (Serum concentrations)
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (Cmax)
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (AUC)
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (Tmax)
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (t1/2)
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Immunogenicity of AZD6621
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Tumour STEAP2 expression
Time frame: Up to 3 years
Eligibility criteria
Study locations (6)
Research Site
Orlando, Florida, 32806
Research Site
Tampa, Florida, 33612
Research Site
Boston, Massachusetts, 02114
Research Site
Grand Rapids, Michigan, 49546
Research Site
Commack, New York, 11725
Research Site
Providence, Rhode Island, 02903