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This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD8359. The study is split into different modules which will look at AZD8359 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels and dosing schedules of AZD8359 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 AZD8359 doses in a larger group of participants (dose expansion).
This is a first-in-human, modular, Phase I/II, open label, multicenter study of AZD8359, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating the the safety, tolerability, preliminary efficacy, immune cell activation and anti-tumor activity of AZD8359. The study will also characterize the pharmacokinetics and immunogenicity of AZD8359.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1 - Part A (Dose Escalation) | Experimental |
| |
| Module 2 - Part A (Dose Escalation) | Experimental |
| |
| Module 1/2 - Part B1 (Dose Expansion) | Experimental |
| |
| Module 1/2 - Part B2 (Dose Expansion) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8359 | Drug | AZD8359 Monotherapy Administration route 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | From first study dose to 21 OR 28 days post first dose based on schedule |
| PSA response rate (Part B only) | Number of participants with a PSA50 response | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response rate (Part A only) | Number of participants with a PSA50 response | Up to 3 years |
| PSA Response rate | Number of participants with a PSA90 response |
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Inclusion Criteria:
Exclusion Criteria:
Male, as assigned at birth, inclusive of all gender identities
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Orlando | Florida | 32806 | United States | |
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from
AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a first in human, multicenter, open-label, dose-escalation and dose-expansion study. The study includes 2 Modules; Module 1 is investigating AZD8359 given on its own by one method of administration, and Module 2 is investigating AZD8359 on its own by a different method of administration. The study also has 2 parts: Part A Dose Escalation and Part B Dose Expansion. Part B Dose expansion will assess at least 2 doses or dosing schedules in either module. Participants will be randomised in Part B to one of these cohorts whenever possible
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| AZD8359 |
| Drug |
AZD8359 Monotherapy Administration route 2 |
|
| AZD8359 | Drug | AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1) |
|
| AZD8359 | Drug | AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2) |
|
| Up to 3 years |
| Time to PSA response | Time taken to achieve a PSA response | Up to 3 years |
| Duration of PSA response | Time PSA response lasts | Up to 3 years |
| Durable PSA response rate | Percentage of participants who have a confirmed PSA response with a duration of at least 6 months | Up to 3 years |
| Time to PSA progression | Time to achieve PSA progression after a PSA response | Up to 3 years |
| Objective Response Rate (ORR) | Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease | Up to 3 years |
| Duration of Response (DoR) | Time from the date of first Objective Response (OR) until date disease progression or death in the absence of disease progression according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease | Up to 3 years |
| Disease Control Rate (DCR) | Percentage of participants who have a Best Overall Response (BOR) of confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease | 16 Weeks |
| Time To Response (TTR) | Time from study drug administration date until the date of first Objective Response (OR) according to RECIST v1.1 for soft tissue disease and PCWG3 for bone disease | Up to 3 years |
| Radiographic Progression Free Survival (rPFS) | The time from the start of study treatment (Part A) or date of randomization (Part B) until disease progression or death in the absence of disease progression according to RECIST 1.1 for soft tissue disease and PCWG3 for bone disease | Up to 3 years |
| Durable Response Rate (DRR) | Percentage of participants who have a confirmed best overall response of Complete Response or Partial Response with a duration at specific milestones (e.g., 3 months, 6 months, 12 months) | Up to 3 years |
| Target Lesion Percentage change | Percentage change in Target Lesion size according to RECIST v1.1. | Up to 3 years |
| Overall Survival (OS) 12 months | Overall Survival at 12 months | 12 months |
| Overall Survival (OS) | Median Overall Survival | Up to 3 years |
| Symptomatic Skeletal Related Events (SSRE) | Time to first symptomatic skeletal-related events (SSRE) | Up to 3 years |
| Serum Concentration of AZD8359 | Serum concentrations of the study drug | From first dose through Day 28 after the last study-drug dose, at predefined intervals |
| Pharmacokinetics of AZD8359 (Cmax) | Maximum observed plasma concentration of the study drug (Cmax). | From first dose through Day 28 after the last study-drug dose, at predefined intervals |
| Pharmacokinetics of AZD8359 (AUC) | Area under the plasma concentration-time curve (AUC) | From first dose through Day 28 after the last study-drug dose, at predefined intervals |
| Pharmacokinetics of AZD8359 (Tmax) | The time it takes for study drug to reach the maximum concentration (Tmax) | From first dose through Day 28 after the last study-drug dose, at predefined intervals |
| Pharmacokinetics of AZD8359 (Clerance) | The volume of plasma completely cleared of a study drug per unit of time | From first dose through Day 28 after the last study-drug dose, at predefined intervals |
| Pharmacokinetics of AZD8359 (t1/2) | Terminal elimination half life of study drug (t1/2) | From first dose through Day 28 after the last study-drug dose, at predefined intervals |
| Immunogenicity of AZD8359 (ADA) | The number and percentage of participants who develop detectable anti-drug antibodies (ADA) | From first dose through Day 28 after the last study-drug dose, at predefined intervals |
| Tumor STEAP2 expression | STEAP2 expression in tumor as measured by immunohistochemistry (IHC) | Up to 3 years |
| Not yet recruiting |
| East Brunswick |
| New Jersey |
| 08816 |
| United States |
| Research Site | Not yet recruiting | Hackensack | New Jersey | 07601 | United States |
| Research Site | Not yet recruiting | Providence | Rhode Island | 02903 | United States |
| Research Site | Not yet recruiting | Darlinghurst | 2010 | Australia |
| Research Site | Recruiting | Melbourne | 3000 | Australia |
| Research Site | Recruiting | Seoul | 03722 | South Korea |
| Research Site | Recruiting | Seoul | 06351 | South Korea |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |