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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8
Research Site
Tampa, Florida, United States
NOT_YET_RECRUITINGResearch Site
Boston, Massachusetts, United States
WITHDRAWNResearch Site
Grand Rapids, Michigan, United States
RECRUITINGResearch Site
Commack, New York, United States
NOT_YET_RECRUITINGResearch Site
Providence, Rhode Island, United States
RECRUITINGResearch Site
Beijing, China
NOT_YET_RECRUITINGResearch Site
Guangzhou, China
SUSPENDEDResearch Site
Nanjing, China
NOT_YET_RECRUITINGResearch Site
Chūōku, Japan
NOT_YET_RECRUITINGResearch Site
Hirakata-shi, Japan
RECRUITING...and 3 more locations
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
Preliminary anti-tumour activity of AZD6621 (PSA Response rate) (Part A only)
• Number of participants with a PSA response rate
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (time to PSA response)
• Time taken to achieve a PSA response
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (duration of PSA response)
• Time PSA response lasts
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (durable PSA response rate)
• Percentage of participants who have a confirmed PSA response with a duration of at least 6 months
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (time to PSA progression)
• Time taken to achieve PSA progression
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (Radiological Response - RECIST)
• Radiological response: according to RECIST v1.1 (soft tissue) and PCWG3 (bone)
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (Radiological Response - Target Lesion Percentage change)
• Percentage change in Target Lesion size according to RECIST v1.1.
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (Overall Survival 12 months)
• Overall Survival at 12 months
Time frame: 12 months
Preliminary anti-tumour activity of AZD6621 (Overall Survival)
• Median Overall Survival
Time frame: Up to 3 years
Preliminary anti-tumour activity of AZD6621 (SSRE)
• Time to first symptomatic skeletal-related events (SSRE)
Time frame: Up to 3 years
Pharmacokinetics of AZD6621 (Serum concentrations)
• Serum concentrations of the study drug.
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (Cmax)
• Maximum observed plasma concentration of the study drug (Cmax).
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (AUC)
• Area under the plasma concentration-time curve (AUC).
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (Tmax)
• The time it takes for study drug to reach the maximum concentration (Tmax).
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Pharmacokinetics of AZD6621 (t1/2)
• Terminal elimination half life of study drug (t1/2)
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Immunogenicity of AZD6621
• The number and percentage of participants who develop detectable anti-drug antibodies (ADA).
Time frame: From first dose of study intervention to 28 days post last dose of study intervention
Tumour STEAP2 expression
• STEAP2 expression in tumour as measured by immunohistochemistry (IHC)
Time frame: Up to 3 years
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.