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
Qualifiers
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
Treatments tested in this trial
- Pimicotinib (ABSK021)
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov