A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer

Официальное название

A Multicenter, Open-Label Phase II Study To Evaluate The Efficacy And Safety Of ABSK021 In Combination With Chemotherapy With Or Without Toripalimab In Patients With Advanced Pancreatic Cancer

Обзор

The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with advanced pancreatic cancer. The main questions it aims to answer are: * Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is safe in patients with advanced pancreatic cancer. * Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is effective in patients with advanced pancreatic cancer. Participants will be asked to complete the study procedures: * Receive the administration of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab about 24 weeks in study Part A or Part B. * Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2. * Complete the study procedures specified in the protocol, which is guided by researchers.

Подробное описание

This is a phase II, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with advanced pancreatic cancer.

Вмешательства

• Препарат Pimicotinib (ABSK021)
  The ABSK021 will be taken orally, once daily; The Gemcitabine and nab-Pacilitaxel will be administrated with intravenous infusion on day 1 and 8 of each cycle; The Toripalimab will be administrated with intravenous infusion on day 1 of each cycle.

Первичные конечные точки

• Safety Event Occurance [Срок оценки: From the day signed informed consent form to day 90 after the end of cycle 8 (each cycle is 21 days)]
• Objective Response Rate (ORR) [Срок оценки: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)]

Вторичные конечные точки (6)

• Duration of Response [Срок оценки: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)]
• Progression Free Survival [Срок оценки: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)]
• Overall Survival [Срок оценки: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)]
• The exposure of ABSK021 [Срок оценки: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)]
• The Maximum Concentration of ABSK021 [Срок оценки: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)]
• The Minimum Concentration of ABSK021 [Срок оценки: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)]

Критерии участия

Критерии включения

• Male and female aged 18-75 years old. The subjects must have informed consent to the study, and signed the written informed consent voluntarily.
• Diagnosis as non resectable local advanced or metastatic pancreatic cancer by histology or cytology.
• Measurable disease as defined by RECIST 1.1.
• Without systemic treatment for pancreatic cancer.
• ECOG physical strength score 0-2
• Estimated survival time >=3 months.
• The adequate bone marrow fuction and coagulation function

Критерии исключения

• Known allergy or hypersensitivity to any components of the investigational drug product.
• Previous treatment with highly selective inhibitors targeting Colony Stimulating Factor 1 (CSF-1)/Colony Stimulating Factor 1 Receptor (CSF-1R).
• With Breast Cancer Gene 1/2 (BRCA1/2) gene mutation.
• With a history of other malignancies within 5 years.
• During the trial, other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for local symptomatic radiotherapy) or traditional Chinese medicine must be used for anti-tumor treatment.
• With conditions that significantly affected the absorption of oral drug.
• Surgical treatment is required within 4 weeks before the first administration, or unhealed, infected, or dehiscence of previous surgical wounds.
• During the 2 weeks prior to the first administration of this study, the patient was receiving chronic systemic steroid treatment or any other form of immunosuppressive treatment.
• Concomitant use of strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4) within 14 days prior to randomization.
• Previous peripheral neuropathy > grade 1 (Common Terminology Criteria for Adverse Events, version 5.0).
• Diagnosed with immune deficiency or interstitial lung disease.
• The patients were vaccinated within 4 weeks before the first treatment.
• Participated in any drug clinical trial within 4 weeks before the first treatment.
• Active central nervous system (CNS) metastases.
• Impaired cardiac function or clinically significant cardiac disease.
• Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study.
• Known active infections from certain viruses, bacteria or parasites.
• Patients with refractory/uncontrolled ascites or pleural effusion.
• Pregnant or lactating women.
• Any other clinically significant comorbidities, which in the judgment of the Investigator, should not be included.

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 · 5 центров

• Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Шанхай
• West China Hospital of Sichuan University — Чэнду
• Harbin Medical University Cancer Hospital — Ha’erbin
• Shanghai East Hospital Tongji University — Шанхай
• Union Hospital Tongji Medical College Huazhong University of science and technolog — Ухань

Идентификаторы

NCT: NCT06111274 · ABSK021-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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