A Phase II Study of SYHA1813 for Recurrent or Progressive High-Grade Meningioma

Официальное название

SYHA1813 vs Investigators' Choice as Treatment for Recurrent or Progressive High-Grade Meningioma: A Randomized, Controlled, Multicenter, Phase II Study

Обзор

This is a randomized, controlled, open-label, multicenter, Phase II clinical study designed to evaluate the efficacy and safety of SYHA1813 compared to investigators' choice in participants with recurrent or progressive high-grade meningioma.

Подробное описание

A total of 56 participants with recurrent or progressive high-grade meningioma who are not eligible for local therapy will be enrolled. Participants will be randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group). The primary endpoint is the 6-month progression-free survival (PFS) rate assessed by investigators using the Response Assessment in Neuro-Oncology Working Group（ RANO criteria） for meningioma.

Вмешательства

• Препарат SYHA1813
  The starting dose of SYHA1813 is 20mg QD
• Препарат Investigator's Choice Treatment
  Investigator's Choice Treatment

Первичные конечные точки

• the Progression-free survival (PFS) at 6-month（PFS-6）as evaluated by investigator (RANO-meningioma) [Срок оценки: Up to approximately 3years]

Вторичные конечные точки (9)

• Progression-free survival (PFS) as evaluated by INV (RANO-meningioma) [Срок оценки: Up to approximately 3years]
• Objective response rate (ORR) as evaluated by INV (RANO-meningioma) [Срок оценки: Up to approximately 3years]
• Disease control rate (DCR) as evaluated by INV (RANO-meningioma) [Срок оценки: Up to approximately 3years]
• Overall survival (OS) [Срок оценки: Up to approximately 3years]
• Frequency and severity of TEAE and SAE [Срок оценки: Up to approximately 3years]
• Maximum Plasma Concentration of SYHA1813 (Cmax) [Срок оценки: Up to approximately 3years]
• The scores of the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) [Срок оценки: Up to approximately 3years]
• The scores of the 20-item EORTC QLQ for Brain Neoplasm (-BN20) [Срок оценки: Up to approximately 3years]
• The score of The Neurologic Assessment in Neuro-Oncology (NANO) scale [Срок оценки: Up to approximately 3years]

Критерии участия

Критерии включения

• Aged >= 18 years;
• Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th)
• There is at least one measurable lesion in the baseline period (RANO-meningioma);
• KPS≥60;
• The expected survival time is >=3 months;
• The organ function level and related laboratory indicators must meet requirements (no blood transfusion within 2 weeks):
• Female participants of childbearing potential must have a negative the blood pregnancy test results of within 7 days prior to randomization and agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions). Male participants with partners of childbearing potential must agree to use reliable and effective contraception during the study treatment period and for at least 3 months after the last study treatment (or as required by the drug's instructions).

Критерии исключения

• Patients who are known or suspected to be allergic to the test drug or its components;
• Meets one of the following conditions: patients with brainstem involvement; patients with severe brain herniation or at risk of brain herniation; patients with extracranial metastasis during the screening period.
• A history of any other malignant tumors within 3 years (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured carcinoma in situ);
• Use of glucocorticoids at an equivalent dose exceeding 5mg of dexamethasone within 7 days prior to randomization.
• The toxicity of previous anti-tumor treatments has not recovered to Grade1(including brain edema after radiotherapy), with the exception of hair loss, uncomplicated laboratory abnormalities that do not require medical intervention, and other adverse reactions deemed by the investigator not to affect the safety of the study medication.;
• Use of a strong CYP3A4 inhibitor within 14 days prior to randomization or ongoing use of such inhibitors.
• Current use of warfarin or other oral anticoagulants (except for low-dose anticoagulants used to maintain central venous access or prevent deep vein thrombosis).
• Inability to undergo contrast-enhanced MRI
• Patients with evidence of bleeding tendency or medical history within 2 moths
• Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g/24h;
• Human immunodeficiency virus (HIV) antibody positive; active hepatitis C (anti-HCV antibody positive and HCV RNA test positive); active hepatitis B (HBV DNA test for HBsAg is positive and HBV DNA is equal to or higher than 2×10\^3 IU/ml));
• The subject has poorly healed wounds, ulcers or fractures;
• Presence of a severe chronic or active infection (including tuberculosis and other infections).requiring intravenous antibiotic, antifungal, or antiviral treatment within 14 days prior to randomization
• Other severe systemic diseases, including but not limited to uncontrolled diabetes, kidney disease requiring dialysis, severe liver disease (Child-Pugh class B or C), acute pancreatitis, etc.
• Subjects with clinically significant cardiovascular and cerebrovascular diseases.
• Underwent major organ surgery within 28 days prior to randomization (excluding biopsy procedures).
• Received chemotherapy (including temozolomide), targeted therapy, immunotherapy, hormone therapy, or other antitumor treatments within 28 days prior to randomization; or used any NMPA-approved traditional Chinese medicine or patent Chinese medicine with anticancer activity within 14 days prior to randomization (regardless of cancer type).
• Subjects with dysphagia or known drug absorption disorders.
• Pregnant or lactating women.
• Presence of other conditions that may interfere with the participant's ability to comply with the study procedures or that may not allow the participant to derive the maximum benefit from the study, or that may affect the study outcomes, such as a history of psychiatric disorders, drug or substance abuse, or any other clinically significant disease or condition.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06739213 · SYHA1814-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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