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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:
Participants will be asked to complete the study procedures:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABSK021 with chemotherapy | Experimental | 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. |
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| ABSK021 in combination with chemotherapy plus the Toripalimab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimicotinib (ABSK021) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Event Occurance | The Number of Participants With Adverse Event (AE), a Serious Adverse Event (SAE) and Dose Limiting Toxicities (DLT) Event. | 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) | From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YUAN LU | Contact | +86-21-68910052 | clinical@abbisko.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| 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. | 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. | 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. | 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) | 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) | From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days) |
| West China Hospital of Sichuan University | Recruiting | Chengdu | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Ha’erbin | China |
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| Shanghai East Hospital Tongji University | Recruiting | Shanghai | China |
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| Union Hospital Tongji Medical College Huazhong University of science and technolog | Recruiting | Wuhan | China |
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| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |