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RECRUITING
NCT06111274
PHASE2

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

Sponsor: Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2023-10-17

Completion Date

2026-12-29

Last Updated

2024-04-11

Healthy Volunteers

No

Interventions

DRUG

Pimicotinib (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