A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.

Официальное название

A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.

Обзор

This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.

Вмешательства

• Препарат SPH4336
  SPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
• Препарат Cadonilimab
  Intravenous infusion, 6mg/Kg,28 days/cycle

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Approximately 2 years]

Вторичные конечные точки (8)

• Objective response rate (ORR) [Срок оценки: Approximately 2 years]
• progression-free rate（PFR） [Срок оценки: Approximately 2 years]
• Cmax [Срок оценки: Approximately 2 years]
• Tmax [Срок оценки: Approximately 2 years]
• Disease control rate (DCR) [Срок оценки: Approximately 2 years]
• Duration of remission (DOR) [Срок оценки: Approximately 2 years]
• Overall Survival (OS) [Срок оценки: Approximately 8 years]
• Incidence of Adverse event [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• Subjects voluntarily participate in this study and sign informed consent.
• Expected survival ≥3 months.
• Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
• According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
• The laboratory test results meet the organ function requirements before starting the study treatment.
• Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.
• Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.

Критерии исключения

• Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
• Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
• Had a history of other malignancies before starting the study.
• History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
• Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
• Previous history of organ transplantation.
• Before starting the study, HBsAg positive patients with HBV DNA > 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.
• Accompanied by any other serious, progressive, or uncontrolled disease.
• Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
• History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.
• Women who are pregnant or breastfeeding.
• Any other reason for which patients are ineligible for the study as assessed by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 16 центров

• Fujian Cancer Hospital — Фучжоу
• The First Affiliated Hospital，Sun Yat-sen University — Гуанчжоу
• Henan Cancer Hospital — Чжэнчжоу
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань
• Xiangya Hospital Central South University — Чанша
• The Central Hospital of Yongzhou — Yongzhou
• Liaoning Cancer Hospital & Institute — Шэньчжэнь
• Xijing Hospital — Xi’an
• … и ещё 8 центров

Идентификаторы

NCT: NCT05944224 · SPH4336-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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