A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: AZD6621
- Registration Number
- NCT07192614
- Lead Sponsor
- AstraZeneca
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Module 1 - Part A (Dose Escalation) AZD6621 AZD6621 Monotherapy - Administration route 1 Module 2 - Part A (Dose Escalation) AZD6621 AZD6621 Monotherapy - Administration route 2 Module 1/2 - Part B1 (Dose Expansion) AZD6621 AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1) Module 1/2 - Part B2 (Dose Expansion) AZD6621 AZD6621 Monotherapy - Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE) From time of Informed Consent to 90 days post last dose of study intervention (up to 3 years) • 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
Number of participants with dose-limiting toxicity (DLT), as defined in the protocol (Part A only) From first study dose to 21 to 28 days post first dose • 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.
Preliminary anti-tumour activity of AZD6621 (PSA Response Rate) (Part B only) Up to 3 years • Number of participants with a PSA response rate
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of AZD6621 (Cmax) From first dose of study intervention to 28 days post last dose of study intervention • Maximum observed plasma concentration of the study drug (Cmax).
Preliminary anti-tumour activity of AZD6621 (PSA Response rate) (Part A only) Up to 3 years • Number of participants with a PSA response rate
Preliminary anti-tumour activity of AZD6621 (time to PSA response) Up to 3 years • Time taken to achieve a PSA response
Preliminary anti-tumour activity of AZD6621 (duration of PSA response) Up to 3 years • Time PSA response lasts
Preliminary anti-tumour activity of AZD6621 (durable PSA response rate) Up to 3 years • Percentage of participants who have a confirmed PSA response with a duration of at least 6 months
Preliminary anti-tumour activity of AZD6621 (time to PSA progression) Up to 3 years • Time taken to achieve PSA progression
Preliminary anti-tumour activity of AZD6621 (Radiological Response - RECIST) Up to 3 years • Radiological response: according to RECIST v1.1 (soft tissue) and PCWG3 (bone)
Pharmacokinetics of AZD6621 (Tmax) From first dose of study intervention to 28 days post last dose of study intervention • The time it takes for study drug to reach the maximum concentration (Tmax).
Preliminary anti-tumour activity of AZD6621 (Radiological Response - Target Lesion Percentage change) Up to 3 years • Percentage change in Target Lesion size according to RECIST v1.1.
Preliminary anti-tumour activity of AZD6621 (Overall Survival 12 months) 12 months • Overall Survival at 12 months
Preliminary anti-tumour activity of AZD6621 (Overall Survival) Up to 3 years • Median Overall Survival
Preliminary anti-tumour activity of AZD6621 (SSRE) Up to 3 years • Time to first symptomatic skeletal-related events (SSRE)
Pharmacokinetics of AZD6621 (Serum concentrations) From first dose of study intervention to 28 days post last dose of study intervention • Serum concentrations of the study drug.
Pharmacokinetics of AZD6621 (AUC) From first dose of study intervention to 28 days post last dose of study intervention • Area under the plasma concentration-time curve (AUC).
Pharmacokinetics of AZD6621 (t1/2) From first dose of study intervention to 28 days post last dose of study intervention • Terminal elimination half life of study drug (t1/2)
Immunogenicity of AZD6621 From first dose of study intervention to 28 days post last dose of study intervention • The number and percentage of participants who develop detectable anti-drug antibodies (ADA).
Tumour STEAP2 expression Up to 3 years • STEAP2 expression in tumour as measured by immunohistochemistry (IHC)
Trial Locations
- Locations (1)
Research Site
🇰🇷Seoul, South Korea
Research Site🇰🇷Seoul, South Korea