Идёт набор NCT07020221

A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

Фаза I / Фаза II С лечением Pancreatic Ductal Adenocarcinoma Non Small Cell Lung Cancer Colorectal Cancer Solid Tumor, Adult

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, Carboplatin + Pemetrexed + Pembrolizumab, Gemcitabine.
Кому может быть актуально: Состояния в реестре: Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult. 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 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors

Обзор

This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.

Вмешательства

Препарат VS-7375
VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D (ON/OFF) inhibitor.
Препарат Cetuximab
Cetuximab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR).
Препарат Carboplatin + Pemetrexed + Pembrolizumab
A combination therapy regimen used as a first-line treatment for advanced non-squamous non-small cell lung cancer.
Препарат Gemcitabine
A chemotherapy used for the treatment of several types of cancer including advanced or metastatic pancreatic ductal adenocarcinoma.
Препарат Gemcitabine + Nab-paclitaxel
A chemotherapy regimen used for the treatment of advanced or metastatic pancreatic ductal adenocarcinoma.

Первичные конечные точки

Part A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375 [Срок оценки: Up to 2.5 years]
Part A: To identify the MTD or MFD [Срок оценки: Cycle 1 (each cycle is 21 days)]
Part B: To evaluate the preliminary anticancer activity of the optimal VS-7375 regimen [Срок оценки: Up to 2.5 years]
Part C: To characterize the safety, tolerability, and AE profile of VS-7375 in combination regimens. [Срок оценки: From enrollment to the end of treatment; an average of 9 months]
Part C: To identify a recommended dose for subsequent studies of combination dosed VS-7375. [Срок оценки: Cycle 1 (each cycle is 21 or 28 days)]
Part D: To determine the preliminary anticancer activity of the optimal regimen of VS-7375 as identified in Part C [Срок оценки: Up to 2.5 years]

Вторичные конечные точки (5)

Part A: To characterize the PK of VS-7375 as 2L+ monotherapy administered on a daily oral schedule [Срок оценки: Up to 2.5 years]
Part A: To evaluate the preliminary anticancer activity of VS-73753 as 2L+ monotherapy [Срок оценки: Up to 2.5 years]
Parts B and D: To characterize the safety, tolerability, and AE profile of the recommended VS-7375 regimens from Part A and Part C [Срок оценки: Up to 2.5 years]
Parts B, C, and D: To continue to evaluate the PK of VS-7375 as monotherapy and in combination with other systemic therapies [Срок оценки: Up to 2.5 years]
Part C: Cohort C3: To evaluate the impact of VS-7375 on nab-paclitaxel PK [Срок оценки: Up to 2.5 years]

Критерии участия

Критерии включения

Individuals ≥18 years of age.
Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ function
Adequate cardiac function
Recovered from all AEs due to previous therapies to Grade ≤1 or baseline.
Agreement to use highly effective contraception

Критерии исключения

Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1,
Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1
Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.
History of treatment with direct and specific KRAS G12D inhibitors.
Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
Inability to swallow oral medications.
Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease
Individuals who are pregnant or breastfeeding.

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

Здоровые добровольцы: Нет