A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
ConditionAdvanced Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbbisko Therapeutics Co, Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Pimicotinib (ABSK021)
DrugThe 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.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: ABSK021 with chemotherapyExperimental treatment 1 intervention
Group B: ABSK021 in combination with chemotherapy plus the ToripalimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety 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)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov