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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Harbin Medical University Cancer Hospital
RECRUITING
Ha’erbin
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai East Hospital Tongji University
RECRUITING
Shanghai
Union Hospital Tongji Medical College Huazhong University of science and technolog
RECRUITING
Wuhan
Contact Information
Primary
YUAN LU
clinical@abbisko.cn
+86-21-68910052
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2026-12-29
Participants
Target number of participants: 82
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Abbisko Therapeutics Co, Ltd

This content was sourced from clinicaltrials.gov

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