Идёт набор NCT05519449

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Фаза I С лечением Prostate Cancer Metastatic Castration-resistant Prostate Cancer Castration Resistant Prostatic 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: JANX007, Darolutamide.
Кому может быть актуально: Состояния в реестре: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer. Базовые параметры: 18 лет — 100 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, Австралия
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, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Обзор

This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX007 in adults with metastatic castration-resistant prostate cancer (mCRPC).

Вмешательства

Биопрепарат JANX007
JANX007 is dosed via IV in a 21- or 28-day cycle.
Препарат Darolutamide
Darolutamide is dosed via oral tablets

Первичные конечные точки

Incidence of Dose Limiting Toxicities (DLT) [Срок оценки: 3 years]
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [Срок оценки: 3 years]

Вторичные конечные точки (8)

Area under the concentration time curve to infinity of JANX007 (AUC0-inf) [Срок оценки: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)]
Maximum observed concentration of JANX007 (Cmax) [Срок оценки: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 3 years)]
Number of participants who develop anti-drug antibodies against JANX007 [Срок оценки: Up to 3 years]
Duration of Response [Срок оценки: Up to 3 years]
Prostate Specific Antigen (PSA) response [Срок оценки: Up to 3 years]
Radiographic Progression Free Survival (rPFS) [Срок оценки: Up to 3 years]
Overall Response Rate [Срок оценки: Up to 3 years]
Overall Survival [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

Male ≥18 years of age at the time of signing informed consent
Histologically or cytologically confirmed adenocarcinoma of the prostate
For Dose Escalation and Backfill: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible
Adequate organ function
For Monotherapy Expansion Part a: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC or CRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
For Monotherapy Expansion Part b: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC settings
For Monotherapy Expansion Part d: Have received ≤ 1 anti-androgen therapy and a poly(ADP-ribose) polymerase (PARP) inhibitor for mCRPC and have progressed following treatment with the PARP inhibitor
For Combination Expansion: Have received ≤ 1 anti-androgen therapy other than darolutamide in the HSPC setting and ≤ 1 taxane in the mCRPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.

Критерии исключения

Prior solid organ transplant
Prior treatment with PSMA-targeted CAR-T cell therapy or PSMA-CD3, PSMA-CD28 or other CD3 T-cell engaging bispecific antibodies or radioligand therapy
Clinically significant cardiovascular disease
For Monotherapy Expansion Part a: Prior receipt of any treatment other than an ARPI or taxane in the mCRPC setting
For Monotherapy Expansion Part b: Prior receipt of any treatment other than an anti-androgen therapy or prior receipt of a taxane containing regimen or more than 1 prior line of therapy for mCRPC
For Monotherapy Part d: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than an anti-androgen therapy and PARP inhibitor for mCRPC or prior receipt of a taxane in the mCRPC setting
For Combination expansion: More than 1 prior line of therapy for mCRPC or prior receipt of any treatment other than a taxane for mCRPC or prior receipt of Darolutamide or prior receipt of a taxane for HSPC
Active clinically significant infection (bacterial, viral, fungal, mycobacteria or other)
Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

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

Здоровые добровольцы: Нет