RecruitingPhase 2NCT06111274

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

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


Sponsor

Abbisko Therapeutics Co, Ltd

Enrollment

82 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests ABSK021, a new oral targeted therapy, as a first-line treatment for patients with locally advanced or metastatic pancreatic cancer that cannot be surgically removed. Researchers aim to evaluate how well the drug works and whether it is safe. **You may be eligible if...** - You are between 18 and 75 years old with advanced or metastatic pancreatic cancer confirmed by biopsy - You have not received prior systemic treatment for pancreatic cancer - You have measurable disease on scans - Your estimated survival is at least 3 months - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have a BRCA1 or BRCA2 gene mutation - You have had another cancer in the past 5 years - You have a history of interstitial lung disease or immune deficiency - You have active brain metastases (cancer spread to the brain) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPimicotinib (ABSK021)

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.


Locations(5)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, China

Harbin Medical University Cancer Hospital

Ha’erbin, China

Shanghai East Hospital Tongji University

Shanghai, China

Union Hospital Tongji Medical College Huazhong University of science and technolog

Wuhan, China

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NCT06111274


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