SNV4818 in Participants With Advanced Solid Tumors

Официальное название

A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors

Обзор

This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.

Вмешательства

• Препарат SNV4818
  SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
• Препарат Fulvestrant
  Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
• Препарат Palbociclib
  Palbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily

Первичные конечные точки

• Incidence of dose limiting toxicities (DLTs) [Срок оценки: First 28 days of study treatment]
• Treatment Emergent Adverse Events (TEAEs) [Срок оценки: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose]

Вторичные конечные точки (10)

• Maximum observed plasma concentration of SNV4818 [Срок оценки: After 4 weeks (1 cycle) of study treatment]
• Time to reach the maximum observed plasma concentration of SNV4818 [Срок оценки: After 4 weeks (1 cycle) of study treatment]
• Area Under Plasma Concentration (AUC) Time Curve of SNV4818 [Срок оценки: After 4 weeks (1 cycle) of study treatment]
• Half-life of SNV4818 [Срок оценки: After 4 weeks (1 cycle) of study treatment]
• Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity [Срок оценки: After 1 day of study treatment]
• Apparent oral clearance of SNV4818 [Срок оценки: After 4 weeks (1 cycle) of study treatment]
• Apparent volume of distribution of SNV4818 [Срок оценки: After 4 weeks (1 cycle) of study treatment]
• Overall response rate (ORR) [Срок оценки: After 8 weeks on study treatment]
• Disease control rate (DCR) [Срок оценки: After 8 weeks on study treatment]
• Duration of response (DOR) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Advanced or metastatic solid tumor with an activating PIK3CA mutation.
• Refractory to or intolerant of available therapies
• Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Критерии исключения

• Diagnosis of a primary CNS malignancy
• Active brain metastases or carcinomatous meningitis
• Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
• Inadequate organ function
• Clinically significant ECG abnormalities, including QTcF ≥ 470 ms

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate — Los Angeles
• Massachusetts General Hospital — Boston
• Thomas Jefferson University-Sidney Kimmel Cancer Center — Philadelphia
• Sarah Cannon Research Institute — Nashville
• The University of Texas M.D. Anderson Cancer Center — Houston

Австралия · 5 центров

• Chris O'Brien Lifehouse — Camperdown
• Scientia Clinical Research — Randwick
• Monash Health — Clayton
• Peter MacCallum Cancer Centre — Melbourne
• Linear Clinical Research — Nedlands

Канада · 2 центра

• The Ottawa Hospital Cancer Centre — Ottawa
• University Health Network, Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT06736704 · SNV4818-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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