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Trial Title:
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
NCT ID:
NCT06111274
Condition:
Advanced Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pimicotinib (ABSK021)
Description:
The ABSK021 will be taken orally, once daily; The Gemcitabine and nab-Pacilitaxel will be
administrated with intravenous infusion on day 1 and 8 of each cycle; The Toripalimab
will be administrated with intravenous infusion on day 1 of each cycle.
Arm group label:
ABSK021 in combination with chemotherapy plus the Toripalimab
Arm group label:
ABSK021 with chemotherapy
Other name:
Gemcitabine
Other name:
nab-Pacilitaxel
Other name:
Toripalimab
Summary:
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.
Detailed description:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Liwei Wang
Investigator:
Last name:
Liwei Wang
Email:
Principal Investigator
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Dan Cao
Investigator:
Last name:
Dan Cao
Email:
Principal Investigator
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Ha'erbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiwei Li
Investigator:
Last name:
Zhiwei Li
Email:
Principal Investigator
Facility:
Name:
Shanghai East Hospital Tongji University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Quan
Investigator:
Last name:
Ming Quan
Email:
Principal Investigator
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of science and technolog
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Zhang
Investigator:
Last name:
Tao Zhang
Email:
Principal Investigator
Start date:
October 17, 2023
Completion date:
December 29, 2026
Lead sponsor:
Agency:
Abbisko Therapeutics Co, Ltd
Agency class:
Industry
Source:
Abbisko Therapeutics Co, Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06111274
