SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

Официальное название

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

Обзор

To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors

Вмешательства

• Препарат SPH5030 tablets
  SPH5030 tablets orally once or twice daily.

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Up to 24 days]
• Maximum tolerated dose（MTD） [Срок оценки: Up to 24 days]
• Number of patients with adverse events [Срок оценки: Up to 2 years]

Вторичные конечные точки (12)

• Maximum serum concentration (Cmax) of SPH 5030 [Срок оценки: Up to 2 years]
• Time of maximum serum concentration (Tmax) SPH 5030 [Срок оценки: Up to 2 years]
• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030 [Срок оценки: Up to 2 years]
• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030 [Срок оценки: Up to 2 years]
• Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030 [Срок оценки: Up to 2 years]
• Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030 [Срок оценки: Up to 2 years]
• Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030 [Срок оценки: Up to 2 years]
• Terminal rate constant(λz) of SPH5030 [Срок оценки: Up to 2 years]
• Half-life (t1/2) of SPH5030 [Срок оценки: Up to 2 years]
• Total clearance(CL) of SPH5030 [Срок оценки: Up to 2 years]
• Volume of distribution(Vz) of SPH5030 [Срок оценки: Up to 2 years]
• Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030 [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• ECOG performance status of 0 to 1.
• Life expectancy of more than 3 months.
• At least one measurable lesion exists.(RECIST 1.1)
• Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
• Required laboratory values including following parameters:

ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL/min

• Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.
• Blood pregnancy test was negative within 3 days prior to first dose.

Критерии исключения

• Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
• Known active infection within 2 weeks prior to baseline.
• Subjects with third space fluid that can not be controled.
• Subjects with uncontrolled or severe cardiovascular disease.
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
• Subjects with severe lung disease.
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
• Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
• Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
• Uncured other tumors within 5 years.
• Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
• Evidence of chronic active hepatitis B or C
• Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
• Receive any live or attenuated live vaccine within 28 days prior to baseline.
• Evidence of severe allergies.
• Evidence of alcohol or drug abuse.
• Evidence of neurological or psychiatric disorders.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 17 центров

• Anhui provincial hospital — Хэфэй
• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Guangxi Cancer Hospital — Nanning
• The Fourth Hospital of Hebei Medical University — Shijiazhuang
• Harbin Medical University Cancer Hospital — Харбин
• Anyang Cancer Hospital — Anyang
• Henan Cancer Hospital — Чжэнчжоу
• … и ещё 9 центров

Идентификаторы

NCT: NCT05245058 · SPH5030-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗