Идёт набор NCT06801236

Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer

Фаза I С лечением Prostate Cancer (Adenocarcinoma) mCRPC (Metastatic Castration-resistant Prostate Cancer)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ACE-232 tablets.
Кому может быть актуально: Состояния в реестре: Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer). Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)

Обзор

This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).

Подробное описание

The study consists of two parts, Phase 1A dose escalation and Phase 1B dose optimization. Phase 1A aims to assess the safety, tolerability, pharmacokinetic (PK) profile, and changes in pharmacodynamic (PD) markers in patients treated with ACE-232, and to determine the maximum tolerated dose (MTD), if applicable. In Phase 1B, patients with AR gene alterations will be treated at two different dose levels to establish the recommended Phase 2 dose (RP2D).

Вмешательства

Препарат ACE-232 tablets
ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Первичные конечные точки

Number of patients experiencing adverse events (AEs)/serious adverse events (SAEs) [Срок оценки: From time of information consent to 30 days post last dose, up to approximately 37 months]
Number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol [Срок оценки: From the first dose of ACE-232 on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (at the end of 28 days)]
Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) [Срок оценки: Up to approximately 37 months]

Вторичные конечные точки (8)

Pharmacokinetics characterization by using Area under the plasma concentration versus time curve (AUC) [Срок оценки: Up to approximately 37 months]
Pharmacokinetics characterization by using Maximum concentration (Cmax) [Срок оценки: Up to approximately 37 months]
Prostate Specific Antigen (PSA) response [Срок оценки: Up to approximately 37 months]
Objective Response Rate (ORR) [Срок оценки: Up to approximately 37 months]
Duration of Response (DoR) [Срок оценки: Up to approximately 37 months]
Radiographic Progression Free Survival (rPFS) [Срок оценки: Up to approximately 37 months]
Overall Survival (OS) [Срок оценки: Up to approximately 37 months]
Blood concentration of steroid hormone [Срок оценки: Up to approximately 37 months]

Критерии участия

Критерии включения

Provide written informed consent
Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy
Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment;
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has a life expectancy of at least 6 months
Adequate organ function and bone marrow function

Критерии исключения

Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;
Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong the QT interval.
Any previous treatment-related toxicities have not recovered.
Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.
Severe cardiovascular disorders.
Known gastrointestinal (GI) disorder or GI procedure
History of gastric and duodenal perforation.
History of pituitary dysfunction.
Poorly controlled diabetes mellitus.
Active or uncontrolled autoimmune disease
Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.
Other malignancies requiring treatment within 3 years prior to the first dose of study drug
Known allergy or hypersensitivity to any of the excipients of ACE-232.
Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.

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

Здоровые добровольцы: Нет