A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors

Официальное название

A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors

Обзор

A phase 1, open-label, first-in-human study mainly aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GW01-200 tablets in participants with advanced tumors, including solid tumors and hematological malignancies.

Вмешательства

• Препарат GW01-200
  GW01-200 tablets will be administered orally.

Первичные конечные точки

• Number of participants with adverse events (AEs) and serious AEs (SAEs) [Срок оценки: Up to approximately 2 years]
• Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]
• Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose. [Срок оценки: Up to approximately 2 years]
• Parts C and D: The recommended Phase II Dose (RP2D) of GW01-200 tablets [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (8)

• Maximum concentration (Cmax) [Срок оценки: Up to approximately 2 years]
• Area under the concentration-time curve (AUC) [Срок оценки: Up to approximately 2 years]
• Time to maximum concentration (Tmax) [Срок оценки: Up to approximately 2 years]
• Elimination half-life (t1/2) [Срок оценки: Up to approximately 2 years]
• Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors [Срок оценки: Up to approximately 2 years]
• Duration of response (DoR) [Срок оценки: Up to approximately 2 years]
• Disease control rate (DCR) [Срок оценки: Up to approximately 2 years]
• Progression-free survival (PFS) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

• Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.
• Have at least one measurable target lesion.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Minimum life expectancy ≥ 3 months.
• Adequate organ and marrow function.

Критерии исключения

• Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
• History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.
• Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.
• Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.
• Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.
• Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors.
• Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug.
• Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis.
• Known history of infection with human immunodeficiency virus (HIV).
• Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy.
• For female subjects: currently pregnant or lactating.
• Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc.
• Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator.
• Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking University Cancer Hospital — Пекин
• Zhejiang Cancer Hospital — Ханчжоу

Идентификаторы

NCT: NCT07629258 · GW01-200-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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