Идёт набор NCT07659795

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

Фаза II С лечением Colorectal 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: VS-7375, cetuximab, panitumumab, Cetuximab + mFOLFOX6.
Кому может быть актуально: Состояния в реестре: Colorectal Cancer. Базовые параметры: от 18 лет · Все.
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 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)

Обзор

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer

Вмешательства

Препарат VS-7375
Taken by mouth
Препарат cetuximab
Intravenous infusion
Препарат panitumumab
Intravenous infusion
Препарат Cetuximab + mFOLFOX6
Intravenous infusion

Первичные конечные точки

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 - 2L CRC only [Срок оценки: 6 months]
To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab or panitumumab, administered on a daily oral schedule in participants with KRAS G12D-mutated 2L+ CRC [Срок оценки: 6 months]
To characterize the safety and tolerability of VS-7375 in combination with cetuximab + mFOLFOX, administered on a daily oral schedule in participants with KRAS G12D-mutated 1L CRC [Срок оценки: 6 months]

Вторичные конечные точки (6)

Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments [Срок оценки: 24 months]
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax [Срок оценки: 20 weeks]
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC [Срок оценки: 20 weeks]
To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type [Срок оценки: Up to 2.5 years]
To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30) [Срок оценки: 24 months]
Time to next therapy [Срок оценки: 24 months]

Критерии участия

Критерии включения

Histopathology confirmed metastatic CRC
Measurable disease per RECIST 1.1
Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
ECOG PS=0 or 1

2L+ patients:

Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
Have documented disease progression during or following their most recent prior line of therapy
Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.

1L patients:

Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.

Критерии исключения

Have any other documented co-existing common RAS mutation(s)
Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
Major surgery within 4 weeks of first treatment dose
Radiation therapy (RT) within 1 week of first treatment dose
Receipt of prior direct RAS inhibitor
Receipt of more than 1 investigational therapy
Untreated or symptomatic CNS metastasis
Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
Receipt of PPI or H2 blocker within 5 days
Inability to swallow oral medication
Other protocol-defined inclusion/exclusion criteria may apply

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

Здоровые добровольцы: Нет