Last updated: April 10, 2024
Sponsor: Abbisko Therapeutics Co, Ltd
Overall Status: Active - Recruiting
Phase
2
Condition
Digestive System Neoplasms
Treatment
Pimicotinib (ABSK021)
Clinical Study ID
NCT06111274
ABSK021-202
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female aged 18-75 years old. The subjects must have informed consent to thestudy, and signed the written informed consent voluntarily.
- Diagnosis as non resectable local advanced or metastatic pancreatic cancer byhistology 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
Exclusion Criteria:
- Known allergy or hypersensitivity to any components of the investigational drugproduct.
- Previous treatment with highly selective inhibitors targeting Colony StimulatingFactor 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 traditionalChinese 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, orunhealed, infected, or dehiscence of previous surgical wounds.
- During the 2 weeks prior to the first administration of this study, the patient wasreceiving chronic systemic steroid treatment or any other form of immunosuppressivetreatment.
- 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 AdverseEvents, 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 abnormalliver 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 theInvestigator, should not be included.
Study Design
Total Participants: 82
Treatment Group(s): 1
Primary Treatment: Pimicotinib (ABSK021)
Phase: 2
Study Start date:
October 17, 2023
Estimated Completion Date:
December 29, 2026
Study Description
Connect with a study center
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu,
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Ha'erbin,
ChinaActive - Recruiting
Shanghai East Hospital Tongji University
Shanghai,
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of science and technolog
Wuhan,
ChinaActive - Recruiting

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