- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111274
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
April 10, 2024 updated by: Abbisko Therapeutics Co, Ltd
A Multicenter, Open-Label Phase II Study To Evaluate The Efficacy And Safety Of ABSK021 In Combination With Chemotherapy With Or Without Toripalimab In Patients With Advanced Pancreatic Cancer
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
82
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: YUAN LU
- Phone Number: +86-21-68910052
- Email: clinical@abbisko.cn
Study Locations
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-
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Chengdu, China
- Recruiting
- West China Hospital of Sichuan University
-
Contact:
- Dan Cao
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Principal Investigator:
- Dan Cao
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Ha'erbin, China
- Recruiting
- Harbin Medical University Cancer Hospital
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Contact:
- Zhiwei Li
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Principal Investigator:
- Zhiwei Li
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Shanghai, China
- Recruiting
- Shanghai East Hospital Tongji University
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Contact:
- Ming Quan
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Principal Investigator:
- Ming Quan
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Wuhan, China
- Recruiting
- Union Hospital Tongji Medical College Huazhong University of science and technolog
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Principal Investigator:
- Tao Zhang
-
Contact:
- Tao Zhang
-
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Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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Contact:
- Liwei Wang
-
Principal Investigator:
- Liwei Wang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABSK021 with chemotherapy
There are 2 cohorts in both part A and Part B. In cohort 1, the participant will receive the treatment of ABSK021 in combination with chemotherapy (the Gemcitabine and nab-Pacilitaxel) , 3 weeks as one cycle, about 8 cycles in total.
|
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.
Other Names:
|
Experimental: ABSK021 in combination with chemotherapy plus the Toripalimab
There are 2 cohorts in both part A and Part B. In cohort 2, the participant will receive the treatment of ABSK021 in combination with chemotherapy (the Gemcitabine and nab-Pacilitaxel), with Toripalimab, 3 weeks as one cycle, about 8 cycles in total.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Event Occurance
Time Frame: From the day signed informed consent form to day 90 after the end of cycle 8 (each cycle is 21 days)
|
The Number of Participants With Adverse Event (AE), a Serious Adverse Event (SAE) and Dose Limiting Toxicities (DLT) Event.
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From the day signed informed consent form to day 90 after the end of cycle 8 (each cycle is 21 days)
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Objective Response Rate (ORR)
Time Frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
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The Percentage of Participants with confirmed Complete Response and Partial Response, in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
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From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response
Time Frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Duration of response (DOR) is defined as the time from the date of the first documentation of confirmed response (Complete Response or Partial Response) to the first objective documentation of progressive disease (PD) per RECIST v1.1 per Investigator assessment, or to death due to any cause in the absence of documented PD.
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From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Progression Free Survival
Time Frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Progression-free survival (PFS) was defined as as the time from the first dose to the first objectively documented disease progression per RECIST v1.1 per Investigator assessment, or death due to any cause in the absence of documented progressive disease (PD).
PFS was analyzed using Kaplan-Meier methods.
|
From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Overall Survival
Time Frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Overall survival (OS) was defined as the time from first dose of study drug to death due to any cause.
OS was calculated using the Kaplan-Meier method.
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From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
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The exposure of ABSK021
Time Frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
The Area Under the Concentration Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Normalized by Dose.
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From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
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The Maximum Concentration of ABSK021
Time Frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Maximum Observed Concentration (Cmax)
|
From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
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The Minimum Concentration of ABSK021
Time Frame: From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Minimum Observed Concentration (Cmin)
|
From the cycle 1 day 1 to the end of cycle 8 (each cycle is 21 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2023
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 29, 2026
Study Registration Dates
First Submitted
October 20, 2023
First Submitted That Met QC Criteria
October 26, 2023
First Posted (Actual)
November 1, 2023
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Gemcitabine
Other Study ID Numbers
- ABSK021-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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