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

Launched by ABBISKO THERAPEUTICS CO, LTD · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Pimicotinib (ABSK021) for patients with advanced pancreatic cancer. The researchers want to find out if Pimicotinib is safe to use alongside chemotherapy, and whether it helps patients feel better or live longer. The trial is looking for men and women between 18 and 75 years old who have been diagnosed with pancreatic cancer that cannot be surgically removed and have not received any other treatments for this type of cancer yet.

Participants in the trial will receive the study medication and chemotherapy for about 24 weeks. They will also have regular check-ups and follow specific procedures set by the researchers to monitor their health throughout the study. It's important to know that there are certain criteria that might exclude someone from participating, such as having a serious allergy to the study drug or having certain other health conditions. This trial is currently recruiting participants, and it offers hope for those affected by advanced pancreatic cancer to potentially access a new treatment option.

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Eligibility criteria

• 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.