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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
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.
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, China
RECRUITINGHarbin Medical University Cancer Hospital
Ha’erbin, China
RECRUITINGShanghai East Hospital Tongji University
Shanghai, China
RECRUITINGUnion Hospital Tongji Medical College Huazhong University of science and technolog
Wuhan, China
RECRUITINGSafety Event Occurance
The Number of Participants With Adverse Event (AE), a Serious Adverse Event (SAE) and Dose Limiting Toxicities (DLT) Event.
Time frame: 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)
The Percentage of Participants with confirmed Complete Response and Partial Response, in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
Duration of Response
Duration of response (DOR) is defined as the time from the date of the first documentation of confirmed response (Complete Response or Partial Response) to the first objective documentation of progressive disease (PD) per RECIST v1.1 per Investigator assessment, or to death due to any cause in the absence of documented PD.
Time frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
Progression Free Survival
Progression-free survival (PFS) was defined as as the time from the first dose to the first objectively documented disease progression per RECIST v1.1 per Investigator assessment, or death due to any cause in the absence of documented progressive disease (PD). PFS was analyzed using Kaplan-Meier methods.
Time frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
Overall Survival
Overall survival (OS) was defined as the time from first dose of study drug to death due to any cause. OS was calculated using the Kaplan-Meier method.
Time frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
The exposure of ABSK021
The Area Under the Concentration Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Normalized by Dose.
Time frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
The Maximum Concentration of ABSK021
Maximum Observed Concentration (Cmax)
Time frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
The Minimum Concentration of ABSK021
Minimum Observed Concentration (Cmin)
Time frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
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