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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 5
- 主要终点
- Safety Event Occurance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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.
研究组 & 干预措施
ABSK021 with chemotherapy
There are 2 cohorts in both part A and Part B. In cohort 1, the participant will receive the treatment of ABSK021 in combination with chemotherapy (the Gemcitabine and nab-Pacilitaxel) , 3 weeks as one cycle, about 8 cycles in total.
干预措施: Pimicotinib (ABSK021) (Drug)
ABSK021 in combination with chemotherapy plus the Toripalimab
There are 2 cohorts in both part A and Part B. In cohort 2, the participant will receive the treatment of ABSK021 in combination with chemotherapy (the Gemcitabine and nab-Pacilitaxel), with Toripalimab, 3 weeks as one cycle, about 8 cycles in total.
干预措施: Pimicotinib (ABSK021) (Drug)
结局指标
主要结局
Safety Event Occurance
时间窗: From the day signed informed consent form to day 90 after the end of cycle 8 (each cycle is 21 days)
The Number of Participants With Adverse Event (AE), a Serious Adverse Event (SAE) and Dose Limiting Toxicities (DLT) Event.
Objective Response Rate (ORR)
时间窗: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
The Percentage of Participants with confirmed Complete Response and Partial Response, in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
次要结局
- The Minimum Concentration of ABSK021(From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days))
- Duration of Response(From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days))
- Progression Free Survival(From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days))
- The exposure of ABSK021(From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days))
- Overall Survival(From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days))
- The Maximum Concentration of ABSK021(From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days))