Идёт набор NCT06804824

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Фаза I С лечением Advanced Solid Tumors

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: VVD-159642, Sotorasib, Trametinib.
Кому может быть актуально: Состояния в реестре: Advanced Solid Tumors. 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 1/1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Kα Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors

Обзор

A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.

Вмешательства

Препарат VVD-159642
Oral capsules
Препарат Sotorasib
Oral tablets
Препарат Trametinib
Oral tablets

Первичные конечные точки

Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs) [Срок оценки: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]]
Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 29 months]
Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs [Срок оценки: Up to approximately 29 months]
Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations [Срок оценки: Up to approximately 29 months]

Вторичные конечные точки (9)

Part 1: Recommended Dose for Expansion (RDE) of VVD-159642 as a Single Agent [Срок оценки: Up to approximately 29 months]
Part 2: Recommended Phase 2 Dose (RP2D) of VVD-159642 as a Single Agent and in Combination with Sotorasib and Trametinib [Срок оценки: Up to approximately 29 months]
Part 2: Overall Response Rate (ORR) [Срок оценки: Up to approximately 29 months]
Part 2: Duration of Response (DoR) [Срок оценки: Up to approximately 29 months]
Part 2: Progression-free Survival (PFS) [Срок оценки: Up to approximately 29 months]
Part 2: Disease Control Rate (DCR) [Срок оценки: Up to approximately 29 months]
Parts 1 and 2: Area Under the Plasma Concentration-time Curve (AUC) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib [Срок оценки: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)]
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib [Срок оценки: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)]
Parts 1 and 2: Half-life (t1/2) of VVD-159642 as a Single Agent and in Combination With Sotorasib and Trametinib [Срок оценки: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days)]

Критерии участия

Критерии включения

For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \[IHC\] 3+ or IHC 2+/fluorescence in situ hybridization \[FISH\] positive) as per local/historical testing.
Have histologically or cytologically confirmed metastatic or unresectable solid tumors.
Measurable disease by RECIST version 1.1 as assessed by the investigator.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Adequate bone marrow, kidney, and liver function as defined in the protocol.
Able to take oral medications.

Критерии исключения

Active central nervous system (CNS) malignancies.
History of cardiac diseases as defined in detail in the protocol.
Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study.
Active hepatitis B infection \[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\].
Active hepatitis C infection (positive anti-hepatitis C virus \[HCV\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).

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

Здоровые добровольцы: Нет