Actively Recruiting
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
Led by Abbisko Therapeutics Co, Ltd · Updated on 2024-04-11
82
Participants Needed
5
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years old who have voluntarily signed informed consent
- Diagnosed with non-resectable locally advanced or metastatic pancreatic cancer confirmed by tissue or cell analysis
- Have measurable disease according to RECIST 1.1 criteria
- Have not received any systemic treatment for pancreatic cancer
- Have an ECOG physical status score of 0 to 2
- Have an expected survival time of at least 3 months
- Have adequate bone marrow and blood clotting function
You will not qualify if you...
- Known allergy or sensitivity to any components of the study drug
- Prior treatment with selective inhibitors targeting CSF-1 or CSF-1R
- Having BRCA1 or BRCA2 gene mutations
- History of other cancers within the past 5 years
- Receiving other anti-tumor therapies during the trial except local symptom-relieving radiotherapy
- Conditions that seriously affect oral drug absorption
- Surgery within 4 weeks before first dose or unhealed/infected surgical wounds
- Use of chronic steroids or immunosuppressants within 2 weeks before first dose
- Use of strong CYP3A4 inhibitors or inducers within 14 days before randomization
- Previous peripheral neuropathy worse than grade 1
- Diagnosed immune deficiency or interstitial lung disease
- Vaccination within 4 weeks before first treatment
- Participation in another drug trial within 4 weeks before first treatment
- Active central nervous system metastases
- Impaired heart function or significant heart disease
- Active liver or biliary disease or other conditions causing abnormal liver tests
- Active infections from certain viruses, bacteria, or parasites
- Uncontrolled ascites or pleural effusion
- Pregnant or breastfeeding women
- Other significant medical conditions judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
3
Harbin Medical University Cancer Hospital
Ha’erbin, China
Actively Recruiting
4
Shanghai East Hospital Tongji University
Shanghai, China
Actively Recruiting
5
Union Hospital Tongji Medical College Huazhong University of science and technolog
Wuhan, China
Actively Recruiting
Research Team
Y
YUAN LU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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