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

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.