Идёт набор NCT06785636

A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC

Фаза I / Фаза II С лечением mCRPC (Metastatic Castration-resistant Prostate Cancer) 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: Pocenbrodib, Pocenbrodib and Darolutamide.
Кому может быть актуально: Состояния в реестре: mCRPC (Metastatic Castration-resistant Prostate Cancer), 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
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

PATHWAY: A Phase 1b/2a, Multicenter, Open- Label Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Обзор

This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)

Подробное описание

This is a Phase 1b/2a multicenter, open-label study to confirm the safety, pharmacokinetics (PK), preliminary antitumor activity, and pharmacodynamics (PD) of pocenbrodib for the treatment of participants with mCRPC who have progressed following prior therapy and have been treated with at least 1 potent anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide).

Phase 1b is a dose escalation and optimization study of pocenbrodib monotherapy and in combination with darolutamide in order to determine the maximum tolerated dose (MTD) in participants (n=80) and to determine the recommended Phase 2 dose(s) (RP2D(s)).

Phase 1b consists of three arms: Arm 1 (50-250mg QD 5/2), Arm 2 (continuous monotherapy, 125mg-150mg BID), and Arm 3 (continuous combination of pocenbrodib 125-150mg BID + darolutamide 600mg BID), with DRC safety gates governing study progression between arms. Arm 3 is considered the safety run-in for the combination therapy.

Phase 2a is a dose expansion portion of the study to further evaluate the combination of pocenbrodib and darolutamide in participants with mCRPC who have progressed following lutetium-Lu-177-vipivotide-tetraxetan (PLUVICTO) and prior to initiation of taxane-based therapy and will consist of 2 cohorts:

Cohort 1: pocenbrodib RP2D high + darolutamide

Cohort 2: pocenbrodib RP2D low + darolutamide

Safety will be monitored by the DRC

Вмешательства

Препарат Pocenbrodib
Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.
Препарат Pocenbrodib and Darolutamide
Pocenbrodib in combination with darolutamide

Первичные конечные точки

Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide [Срок оценки: 28 days]
Phase 1b: Identify the recommended Phase 2 doses of pocenbrodib and in combination with darolutamide [Срок оценки: 28 days]
Phase 2a: Assess the safety and tolerability of the RP2Ds of pocenbrodib in combination with darolutamide [Срок оценки: Through duration of treatment, estimated 6 months]
Phase 2a: Evaluate the efficacy of RP2Ds of pocenbrodib in combination with darolutamide [Срок оценки: Through duration of treatment, estimated 6 months.]

Вторичные конечные точки (12)

Phase 1b: Plasma PK Cmax [Срок оценки: At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first]
Phase 1b: Plasma PK Tmax [Срок оценки: At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first]
Phase 1b: Plasma PK AUC for pocenbrodib [Срок оценки: At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first.]
Phase 1b: Model of cumulative exposure in relation to incidence of adverse events (AEs) [Срок оценки: Through duration of treatment, estimated 6 months.]
Phase 1b: Model of cumulative exposure in relation to incidence of serious adverse events (SAEs) [Срок оценки: Through duration of treatment, estimated 6 months.]
Phase 1b: Model of cumulative exposure in relation to incidence of adverse events of special interest (AESIs) [Срок оценки: Through duration of treatment, estimated 6 months.]
Phase 2a: Characterize the PK of pocenbrodib in combination with darolutamide [Срок оценки: At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first]
Phase 2a: Plasma PK Cmax pocenbrodib/darolutamide [Срок оценки: At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first]
Phase 2a: Plasma PK Tmax pocenbrodib/darolutamide [Срок оценки: At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first]
Phase 2a: Plasma PK AUC0-24 pocenbrodib/darolutamide [Срок оценки: At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first]
Phase 2a: rPFS (radiographic Progression Free Survival) [Срок оценки: Through duration of treatment, estimated 6 months]
Phase 2a: Prostate Specific Antigen (PSA) 50% (PSA50) change from baseline. [Срок оценки: Through duration of treatment, estimated 6 months]

Критерии участия

1b / 2a Inclusion Criteria:

≥18 years of age
Histologic documentation of prostate adenocarcinoma
Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable

1b / 2a Exclusion Criteria:

Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy.
Any liver metastases confirmed by biopsy or evidence of lesions >1 cm consistent with liver metastases on imaging.
Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Cycle 1 Day 1 or 5 half-lives (whichever is shorter).
Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complications.

2a only -key inclusion criteria: