First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer

Официальное название

Phase I/II Dose Escalation & Dose Optimization Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD8359, a CD8-guided T Cell-engaging Antibody That Targets STEAP2, in Adult Participants With Prostate Cancer

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат AZD8359
  AZD8359 Monotherapy Administration route 1
• Препарат AZD8359
  AZD8359 Monotherapy Administration route 2
• Препарат AZD8359
  AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 1 (RDE1)
• Препарат AZD8359
  AZD8359 Monotherapy Administration route 1 (Module 1) or administration route 2 (Module 2) at Recommended Dose for Expansion 2 (RDE2)

Первичные конечные точки

• Number of participants with adverse events (AE), adverse events of special interest (AESI), and serious adverse events (SAE) [Срок оценки: 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) [Срок оценки: From first study dose to 21 OR 28 days post first dose based on schedule]
• PSA response rate (Part B only) [Срок оценки: Up to 3 years]

Вторичные конечные точки (12)

• PSA Response rate (Part A only) [Срок оценки: Up to 3 years]
• PSA Response rate [Срок оценки: Up to 3 years]
• Time to PSA response [Срок оценки: Up to 3 years]
• Duration of PSA response [Срок оценки: Up to 3 years]
• Durable PSA response rate [Срок оценки: Up to 3 years]
• Time to PSA progression [Срок оценки: Up to 3 years]
• Objective Response Rate (ORR) [Срок оценки: Up to 3 years]
• Duration of Response (DoR) [Срок оценки: Up to 3 years]
• Disease Control Rate (DCR) [Срок оценки: 16 Weeks]
• Time To Response (TTR) [Срок оценки: Up to 3 years]
• Radiographic Progression Free Survival (rPFS) [Срок оценки: Up to 3 years]
• Durable Response Rate (DRR) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

• Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer
• Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L)
• PSA value at screening should be ≥ 1ng/mL
• Evidence of disease progression within 6 months prior to screening
• Part A Participants should have received at least 2 prior approved systemic therapies for prostate cancer with at least one androgen receptor pathway inhibitor and at least one taxane regimen if amenable
• Part B Participants should have received an androgen receptor pathway inhibitor for metastatic hormone sensitive prostate cancer or metastatic castration resistant prostate cancer (mCRPC). No prior taxane treatment for mCRPC is allowed for Module 1 and 2 Part B patients
• Adequate organ function
• Body weight ≥ 35 kg

Критерии исключения

• Any clinically relevant cardiac abnormalities such as QT prolongation or uncontrolled cardiac arrythmias
• All prior treatment-related adverse events must have resolved to Grade ≤ 2
• History of Grade ≥ 3 cytokine release syndrome or Grade ≥ 2 immune effector cell-associated neurotoxicity syndrome with prior therapy
• Active or prior documented autoimmune or inflammatory disorders within the past 3 years
• Prior exposure to any STEAP2 targeted agents or TCEs for prostate cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Research Site — Orlando
• Research Site — East Brunswick
• Research Site — Hackensack
• Research Site — Providence

Австралия · 2 центра

• Research Site — Darlinghurst
• Research Site — Melbourne

South Korea · 2 центра

• Research Site — Seoul
• Research Site — Seoul

Идентификаторы

NCT: NCT07529717 · D8040C00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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