A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer

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.

Inclusion criteria

• 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.
• ECOG physical strength score 0-2
• Estimated survival time >=3 months.
• The adequate bone marrow fuction and coagulation function

Exclusion criteria

• 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.