Идёт набор NCT06609005

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Фаза I / Фаза II С лечением Advanced 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: INV-9956.
Кому может быть актуально: Состояния в реестре: Advanced 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 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Обзор

This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.

Подробное описание

This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.

The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion.

Phase 1 dose escalation of INV-9956 follows a real time monitored, PK/PD and safety guided scheme with a traditional 3+3 design for DLT assessment.

Phase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of up to 2 cohorts by different AR gene status:

* Cohort A: AR mutant CRPC * Cohort B: AR wide-type CRPC (optional) Currently enrolling patients under Phase 2.

Вмешательства

Препарат INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate

Первичные конечные точки

Phase 1: Maximum tolerated dose (MTD) [Срок оценки: Within first 28 days of treatment]
Phase 1: Recommended dose range (RDR) [Срок оценки: 12 months]
Phase 2: Evaluate Radiographic progression-free survival (rPFS) [Срок оценки: 12 months]
Phase 2: Evaluate overall response rate (ORR) [Срок оценки: 12 months]

Вторичные конечные точки (10)

Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0 [Срок оценки: 12 months]
Phase 1: Determine the PK using AUC of INV-9956 [Срок оценки: 12 months]
Phase 1: Determine the PK using Cmax of INV-9956 [Срок оценки: 12 months]
Phase 1: Determine the blood concentration of steroid hormone [Срок оценки: 12 months]
Phase 1: Evaluate Radiographic progression-free survival (rPFS) [Срок оценки: 12 months]
Phase 1: Evaluate overall response rate (ORR) [Срок оценки: 12 months]
Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0 [Срок оценки: 12 months]
Phase 2: Determine the PK using AUC of INV-9956 [Срок оценки: 12 months]
Phase 2: Determine the PK using Cmax of INV-9956 [Срок оценки: 12 months]
Phase 2: Determine the blood concentration of steroid hormone [Срок оценки: 12 months]

Критерии участия

Критерии включения

Written informed consent obtained.
Male aged ≥ 18 years.
Histologically confirmed adenocarcinoma of the prostate.
Castration resistant prostate cancer with serum testosterone <50 ng/dL.
Metastatic disease.
Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused or were intolerant to taxane-based chemotherapy may be enrolled.
ECOG performance status 0-1.
Adequate marrow, liver and kidney function.
INR ≤1.5.
Able to swallow study treatment.
Has a life expectancy of > 3 months.

Критерии исключения

Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
History of pituitary or adrenal dysfunction.
Poorly controlled diabetes mellitus.
Clinically significant abnormality in serum potassium and sodium.
Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
Prolonged QTcF interval.
Active infection or other medical condition that would make corticosteroid contraindicated.

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

Здоровые добровольцы: Нет