APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST

Официальное название

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APG-2449 Monotherapy or in Combination With Anticancer Agents in Patients With Platinum-resistant Recurrent Ovarian Cancer or Advanced Solid Tumors

Обзор

An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.

Подробное описание

Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors.

Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.

Вмешательства

• Препарат APG -2449
  Orally once a day(QD), every 28 days as a cycle.
• Препарат PLD
  Injected on the first day of each cycle, every 28 days as a cycle.

Первичные конечные точки

• Treatment-related adverse events per NCI-CTCAE version 5.0. [Срок оценки: Up to 1 year]
• Dose Limiting Toxicity(DLT). [Срок оценки: Up to 28 days]

Критерии участия

Критерии включения

• Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.

Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma.

• At least one measurable tumor lesion.
• ECOG score is 0\~1.
• Life expectancy of ≥3 months.
• AE caused by previous treatment must recover to ≤ grade 1.
• Sufficient bone marrow, liver, kidney and coagulation function.
• Female patients must be in a non-pregnant and non-lactating state.
• Able to understand and willing to sign informed consent.
• Patients are required to provide fresh or archived tumor tissue samples prior to treatment.

Критерии исключения

• Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose.
• Received systemic antitumor drugs, including investigational drugs.
• Received radiotherapy within 14 days before first dose.
• Previous treatment with FAK inhibitors.
• Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.
• Known active central nervous system (CNS) metastases and/or cancerous meningitis.
• Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose.
• Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose.
• Malabsorption syndrome, or inability to take medications orally.
• Severe gastrointestinal disease.
• Any serious or uncontrolled systemic disease; Various chronic active infections.
• Allergy to APG-2449 or PLD and its drug components.
• Previous cumulative doses of anthracyclines ≥550 mg/m\^2.
• Patients using a moderately potent CYP3A4, CYP2C9, or CYP2C19 inhibitor/inducer or P-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates and the drugs of a narrow treatment window within a week before first dose.
• Other factors that, in the investigator's judgment, should prevent the patient from entering the study.

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 · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06687070 · APG2449OC101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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